Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function (PROTECT IV)

• ClinicalTrials.gov Identifier: NCT04763200
• Recruitment Status: Recruiting
• First Posted: February 21, 2021
• Last Update Posted: January 2, 2024
• Sponsor: Abiomed Inc.
• Information provided by (Responsible Party): Abiomed Inc.

Study Description

Brief Summary:

The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health after a heart procedure compared to the current standard of care.

Condition or disease	Intervention/treatment	Phase
Left Ventricular Dysfunction; Coronary Artery Disease	Device: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®; Device: IABP Intra-aortic balloon pump	Not Applicable

Detailed Description:

To demonstrate that in high-risk patients with complex CAD and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes at 3-year follow-up.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, multicenter, randomized, parallel-controlled, open-label two-arm trial with an adaptive design.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function: The PROTECT IV Trial
• Actual Study Start Date: April 13, 2021
• Estimated Primary Completion Date: March 2026
• Estimated Study Completion Date: October 2027

Arms and Interventions

Arm	Intervention/treatment
Experimental: Impella Arm; Impella CP® or Impella 2.5 placement prior to high-risk PCI	Device: Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®; Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI <20 kg/m2 or body weight <60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
Active Comparator: Control Arm; Subjects randomized to the Control group will be treated per standard of care PCI with or without an intra-aortic balloon pump (IABP).	Device: IABP Intra-aortic balloon pump; IABP uses counterpulsation to provide 0.2L/min coronary flow

Outcome Measures

Primary Outcome Measures :

1. The composite of all-cause death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular (CV) causes. [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Death or NYHA Class III or IV [ Time Frame: 1 year ]
2. Improvement in KCCQ [ Time Frame: Baseline to 6 months ]
3. 6MWD [ Time Frame: 6 months ]
4. All CV hospitalizations through 3 years [ Time Frame: 3 years ]
5. Composite of CV death, stroke, MI, unplanned clinically driven revascularization, durable LVAD implant or heart transplant, or other hospitalization for cardiovascular causes through 3 years [ Time Frame: 3 years ]
6. CV death or HF hospitalizations through 3 years [ Time Frame: 3 years ]
7. Improvement in LVEF based on ANCOVA regression with inclusion of baseline LVEF measurement as a covariate [ Time Frame: Baseline to 6 months ]
8. Achievement of complete anatomic revascularization after the index and planned staged procedures [ Time Frame: 3 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 90 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Age ≥18 years and ≤90 years

2. Clinical presentation and baseline left ventricular function are as follows: Either 2A or 2B must be present

   A. Subject has CCS or NSTEMI with an LVEF ≤40% NOTE: The LVEF must be quantitatively measured as ≤40% by echo within 30 days assuming no change in clinical condition. If multiple echos have been performed within 30-days, the most recent test must be used to qualify the patient. NOTE: Subject qualifies if the quantitative site read LVEF is ≤30%; if the quantitative site read is >30% - ≤40% the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment (Core Lab will provide <48-hour turnaround). Similarly, if the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤40% before subject enrollment.

   OR

   B. Subject has STEMI ≥24 hours and <30 days after symptom onset with an LVEF ≤30% NOTE: In patients qualifying with recent STEMI, the LVEF must be demonstrated to be ≤30% by quantitative echocardiography after the primary PCI procedure (if performed) and within 72-hours prior to the planned randomization. If primary PCI was not performed, the qualifying echocardiogram will be the one taken during the index hospitalization closest to the index procedure. If the site read is qualitative only (i.e., only provides broad ranges without detailed LVEF quantification), the Echo Core Lab must confirm the LVEF is ≤30% before subject enrollment.

3. Local heart team (interventional cardiologist and cardiac surgeon) has determined that PCI is indicated and is the most appropriate management for the patient

4. Complex PCI will be performed: Either 4A or 4B must be met

   A. One of the following must be present:

   i. Triple vessel disease is present (visually-assessed angiographic DS ≥80% [or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89)] is present in all 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) with PCI planned in ≥2 of these vessels in the proximal or mid LAD, proximal or mid-LCX or proximal, mid- or distal RCA [i.e., not a branch vessel])

   OR

   ii. Left main distal bifurcation or trifurcation disease (visually-assessed DS ≥50% [or DS ≥30% if non-invasive evidence of ischemia in both the anterior and posterolateral distributions or left main IVUS MLA ≤6.0 mm2 or FFR ≤0.80 or iFR ≤0.89] is present) with planned intervention of the left main plus at least 2 branch vessels (i.e., the ostial LAD, ostial LCX or ostial ramus)

   OR

   iii. Left main equivalent disease with both ostial LAD and ostial LCX having visually-assessed angiographic DS ≥80% [or ≥40% if non-invasive evidence of ischemia on a localizing stress test or invasive evidence of ischemia (FFR ≤0.80 or iFR ≤0.89] and requiring intervention in both branches

   OR

   iv. Intervention of the last remaining vessel (native coronary artery or bypass graft)

   OR

   B. Multivessel disease is present (visually-assessed angiographic DS ≥80% [or ≥40% if non-invasive or invasive evidence of ischemia is present] in ≥2 of the 3 epicardial coronary artery distributions in a main vessel or branch with visually-assessed reference vessel diameter ≥2.5 mm) and PCI is planned of at least 2 separate complex lesions in main vessels or branch vessels each having one or more of the following characteristics:

   i. Long lesion (≥28 mm visually assessed) requiring ≥30 mm stent length (single or multiple)

   ii. Severe angiographic calcification (see Protocol definition) or requiring atheroablation

   iii. Any left main morphology not in Criterion A requiring intervention (e.g., isolated ostial or mid-shaft left main lesion or distal left main bifurcation lesion with a planned single provisional stent technique)

   iv. Non-left main bifurcation lesion requiring intervention in both the main branch and side branch

   v. CTO (TIMI 0 Flow)

   vi. Giant thrombus (length ≥3x vessel diameter)

   vii. SVG (other than focal (<5 mm) disease of the proximal or distal anastomosis or in-stent restenosis)

   NOTES:

   1. The multiple lesions can be in the same vessel if separated by ≥10 mm - however, each separate lesion has to have one or more of the above characteristics
   2. PCI may be performed on additional non-qualifying lesions (i.e., without 1 or more of the above high-risk characteristics) as long as there are at least two lesions also undergoing PCI with each having 1 or more of the above characteristics)
   3. There are 2 exceptions to the rule that each separate lesion must have one or more of the above characteristics (as in Inclusion Criterion 4B above): The subject may qualify if undergoing complex PCI of a single lesion that has 2 or more of the above complex characteristics (as in Inclusion Criterion 4B above) if also:

   i. There is a CTO of a proximal or mid-LAD, proximal or mid-LCX or proximal, mid- or distal RCA (i.e., not a branch vessel) that will not be treated

   OR

   ii. The subject qualifies with recent STEMI with an LVEF ≤30% and the complex PCI is planned in a non-infarct vessel (i.e., a complex PCI in the infarct vessel does not qualify)

5. Subject or legal guardian (permitted at US sites only) agrees to randomization and to follow all study procedures and provides informed, written consent

Exclusion Criteria:

Subjects must not meet ANY of the following Exclusion Criteria to participate in the Trial:

1. STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
2. Cardiogenic shock (SBP <80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
3. Subject is presently or recently intubated for the current admission (NOTE: recently intubated patients must be extubated for >24 hours with full neurologic recovery)
4. Cardiorespiratory arrest related to the current admission unless subject is extubated for >24 hours with full neurologic recovery and hemodynamically stable

5. Any contraindication or inability to Impella placement in both the left and right common femoral artery based on clinical or imaging findings, including iliofemoral artery diameter <5 mm, tortuous vascular anatomy or severe bilateral peripheral vascular disease of the iliac or femoral arteries that can't be adequately treated (e.g., with intravascular lithotripsy)

   NOTES:

   1. Computed tomography (CT), magnetic resonance angiography (MRA) or contrast angiography to assess the aorta and iliofemoral vasculature to ensure Impella compatibility must be performed within 90 days prior to randomization. It is recommended that this evaluation be performed prior to the index procedure. Absent a qualifying pre-procedure imaging study, contrast angiography of the potential Impella access vessel(s) must be performed in the Cath Lab before the planned enrollment after which the subject may be randomized if he/she still qualifies. Of note, if pre-procedure imaging was performed and after this test but before randomization there was a worsening in PVD symptoms, repeat imaging must be performed prior to randomization.
   2. If iliofemoral peripheral vascular disease is present precluding Impella use that can be adequately treated with angioplasty, atherectomy or lithotripsy (without a stent), the subject can be enrolled if such treatment is undertaken and is successful and uncomplicated - randomization must not be performed until such successful and uncomplicated treatment
6. Iliofemoral stents placed within 6 months of enrollment with planned vascular access through these vascular segments
7. Vascular access for Impella is required in any location other than the left or right common femoral artery (i.e., axillary access, transcaval access, etc., for Impella access are not permitted)
8. Known left ventricular thrombus
9. Incessant ventricular arrhythmias that would likely preclude stable Impella positioning
10. Severe aortic stenosis or severe aortic insufficiency
11. Prior mechanical valve or self-expanding TAVR (NOTE: prior bioprosthetic surgical valve or balloon expandable TAVR implanted >24 hours pre-procedure is acceptable)

12. Prior CABG within three (3) months or successful prior PCI of at least one (1) attempted lesion within 12 months (including during the index hospitalization prior to randomization), that has not experienced stent thrombosis or restenosis during that 12-month period; the one (1) exception is that patients may be enrolled if a primary PCI for STEMI was performed during the index hospitalization without MCS and that was ≥24 hours and <30 days prior to randomization.

    NOTE: Successful PCI for this exclusion criterion is defined as a visually-assessed angiographic DS ≤50% in at least one (1) attempted lesion.

13. Prior placement of IABP, Impella or any other MCS device for any reason during the index admission, prior to randomization
14. Known severe pulmonary hypertension (right ventricular systolic pressure (RVSP) on echo or pulmonary artery systolic pressure (PASP) on right heart catheterization) >70 mm Hg unless active vasodilator therapy in the Cath Lab is able to reduce the pulmonary vascular resistance (PVR) to <3 Wood Units or between 3 and 4.5 Wood Units with v-wave less than twice the mean of the pulmonary capillary wedge pressure
15. Symptoms or signs of severe RV dysfunction, such as anasarca (NOTE: Leg edema alone does not necessarily indicate severe RV dysfunction if the investigator believes it is due to LV dysfunction)
16. Severe tricuspid insufficiency
17. Platelet count <75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions
18. On dialysis
19. Prior stroke with any permanent neurologic deficit within the previous three (3) months, or any prior intracranial hemorrhage or any prior subdural hematoma or known intracranial pathology pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
20. Taking a chronic oral anticoagulant that cannot be safely discontinued for at least 72-hours before and 72-hours after the index procedure (if a vitamin K antagonist) or that cannot be safely discontinued for at least 48 hours before and 48 hours after the index procedure (for a direct acting oral anticoagulant)
21. Plan for any surgery within 6 months necessitating discontinuing antiplatelet agents
22. Pregnant or child-bearing potential unless negative pregnancy test within 1 week
23. Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
24. Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
25. Any non-cardiac condition with life expectancy <3 years (e.g., cirrhosis, oxygen or oral steroid dependent COPD, cancer not in remission, etc.)
26. Subject is currently hospitalized for definite or suspected COVID-19
27. Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥4 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
28. Subject is asymptomatic (never ill) and COVID-19 PCR/antigen test is positive within the prior four (4) weeks unless a) subject remains asymptomatic for ≥2 weeks after the last positive test or b) the positive test occurred within six (6) months after the subject received a COVID vaccine
29. Subject belongs to a vulnerable population (defined as individuals with mental disability, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)

Contacts and Locations

Contacts

Contact: Charles (Chuck) Simonton, MD FACC FSCAI; 978-646-1597; csimonton@abiomed.com

Contact: Adam Thompson; 208-271-1610; adthompson@abiomed.com

Locations

United States, Alabama

University of Alabama; Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator: Mustafa Ahmed, MD

United States, Arizona

Abrazo Arizona Heart; Withdrawn

Phoenix, Arizona, United States, 85016

St. Joseph's Medical Center - Phoenix; Recruiting

Phoenix, Arizona, United States, 85016

Principal Investigator: Hursh Naik, MD

Tucson Medical Center HealthCare; Not yet recruiting

Tucson, Arizona, United States, 85712

Principal Investigator: Thomas Waggoner, DO

Northwest Medical Center Tucson; Recruiting

Tucson, Arizona, United States, 85741

Principal Investigator: Dexter Deleon, MD

United States, Arkansas

Washington Regional Medical Center - Walker Heart Institute; Not yet recruiting

Fayetteville, Arkansas, United States, 72703

Principal Investigator: Joel Carver, MD

Arkansas Cardiology; Recruiting

Little Rock, Arkansas, United States, 72205

Principal Investigator: Ernesto Ruiz-Rodriguez, MD

United States, California

Mills-Peninsula Medical Center; Not yet recruiting

Burlingame, California, United States, 94010

Principal Investigator: Elliot Groves, MD

Saint Agnes Medical Center; Not yet recruiting

Fresno, California, United States, 93720

Principal Investigator: Alfred Valles, MD

Adventist Health Glendale; Recruiting

Glendale, California, United States, 91206

Principal Investigator: Hambik Tankazyan, MD

Cedars-Sinai Medical Center; Not yet recruiting

Los Angeles, California, United States, 90048

Principal Investigator: Suhail Dohad, MD

St. Joseph Hospital - Orange; Recruiting

Orange, California, United States, 92868

Principal Investigator: Brian Kolski, MD

Loma Linda University Health; Recruiting

San Bernardino, California, United States, 92354

Principal Investigator: Aditya Bharadwaj, MD

UCSD Medical Center; Recruiting

San Diego, California, United States, 92093

Principal Investigator: Ehtisham Mahmud, MD

Torrance Memorial Medical Center; Not yet recruiting

Torrance, California, United States, 90505

Principal Investigator: Michael Wyman, MD

United States, Colorado

Colorado Heart and Vascular; Recruiting

Lakewood, Colorado, United States, 80228

Principal Investigator: John Altman, MD

United States, District of Columbia

MedStar Washington Hospital Center; Recruiting

Washington, District of Columbia, United States, 20010

Principal Investigator: Hayder Hashim, MD

United States, Florida

Cardiology Associates Research Company; Not yet recruiting

Daytona Beach, Florida, United States, 32117

Principal Investigator: Nathan Valin, MD

The Cardiac & Vascular Institute; Recruiting

Gainesville, Florida, United States, 32605

Principal Investigator: Matheen Khuddus, MD

University of Florida Health - Gainesville; Recruiting

Gainesville, Florida, United States, 32610

Principal Investigator: R. David Anderson, MD

UF Health Jacksonville; Recruiting

Jacksonville, Florida, United States, 32209

Principal Investigator: Daniel Soffer, MD

AdventHealth - Tampa; Not yet recruiting

Tampa, Florida, United States, 33613

Principal Investigator: James Smith, MD

United States, Georgia

Emory University Hospital; Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator: William Nicholson, MD

Northside Cardiovascular Institute; Recruiting

Lawrenceville, Georgia, United States, 30043

Principal Investigator: Michele Voeltz, MD

Wellstar Kennestone Hospital; Withdrawn

Marietta, Georgia, United States, 30060

United States, Hawaii

The Queen's Medical Center; Not yet recruiting

Honolulu, Hawaii, United States, 96813

Principal Investigator: Benjamin Plank, MD

United States, Illinois

Rush University Medical Center; Not yet recruiting

Chicago, Illinois, United States, 60612

Principal Investigator: Hussam Suradi, MD

NorthShore University Health System; Recruiting

Evanston, Illinois, United States, 60201

Principal Investigator: Mark Ricciardi, MD

Northwestern University; Recruiting

Evanston, Illinois, United States, 60208

Principal Investigator: Keith Benzuly, MD

Advocate Christ Medical Center; Recruiting

Oak Lawn, Illinois, United States, 60453

Principal Investigator: Thomas Levin, MD

Memorial Medical Center; Not yet recruiting

Springfield, Illinois, United States, 62781

Principal Investigator: Tony DeMartini, MD

United States, Kentucky

Norton Healthcare - Norton Heart Specialists; Recruiting

Louisville, Kentucky, United States, 40205

Principal Investigator: Sean Stewart, MD

United States, Louisiana

Cardiovascular Institute of the South (Lafayette General Medical Center); Not yet recruiting

Lafayette, Louisiana, United States, 70596

Principal Investigator: Louis Salvaggio, MD

Ochsner Foundation Hospital; Recruiting

New Orleans, Louisiana, United States, 70121

Principal Investigator: Rajan Patel, MD

United States, Massachusetts

Tufts Medical Center; Recruiting

Boston, Massachusetts, United States, 02111

Principal Investigator: Navin Kapur, MD

Massachusetts General Hospital; Recruiting

Boston, Massachusetts, United States, 02114

Principal Investigator: Rahul Sakhuja, MD

Beth Israel Deaconess Medical Center; Recruiting

Boston, Massachusetts, United States, 02215

Principal Investigator: Robert Yeh, MD

United States, Michigan

Henry Ford Hospital; Recruiting

Detroit, Michigan, United States, 48202

Principal Investigator: Mir B. Basir, DO

Ascension St. John Hospital; Recruiting

Detroit, Michigan, United States, 48236

Principal Investigator: Amir Kaki, MD

Spectrum Health; Recruiting

Grand Rapids, Michigan, United States, 49435

Principal Investigator: David Wohns, MD

United States, Minnesota

Metropolitan Heart and Vascular Institute / Metropolitan Cardiology Consultants; Recruiting

Coon Rapids, Minnesota, United States, 55433

Principal Investigator: Jeffrey Chambers, MD

CentraCare (St. Cloud Hospital); Recruiting

Saint Cloud, Minnesota, United States, 56303

Principal Investigator: Thom Dahle, MD

United States, Missouri

SSM Health DePaul Hospital; Recruiting

Bridgeton, Missouri, United States, 63044

Principal Investigator: Divya Verma, MD

St. Luke's Hospital; Recruiting

Kansas City, Missouri, United States, 64111

Principal Investigator: Adam Salisbury, MD

Missouri Baptist Medical Center; Not yet recruiting

Saint Louis, Missouri, United States, 63131

Contact: Marc Haynes mph7052@bjc.org

Principal Investigator: Gus Theodos

United States, New Hampshire

Catholic Medical Center; Recruiting

Manchester, New Hampshire, United States, 03102

Principal Investigator: Stephan Heo, MD

United States, New Jersey

Englewood Hospital; Not yet recruiting

Englewood, New Jersey, United States, 07631

Principal Investigator: Aaron Schwarcz, MD

Hackensack University Medical Center; Recruiting

Hackensack, New Jersey, United States, 07601

Principal Investigator: Haroon Faraz, MD

Morristown Medical Center; Recruiting

Morristown, New Jersey, United States, 07960

Principal Investigator: Dimitrios Karmpaliotis, MD

Jersey Shore University Medical Center; Recruiting

Neptune, New Jersey, United States, 07735

Principal Investigator: Aditya Mehra, MD

Robert Wood Johnson Medical School & Robert Wood Johnson University Hospital; Withdrawn

New Brunswick, New Jersey, United States, 08901

The Valley Hospital - Ridgewood; Recruiting

Ridgewood, New Jersey, United States, 07450

Principal Investigator: Rajiv Tayal

United States, New Mexico

Lovelace/New Mexico Heart Institute; Recruiting

Albuquerque, New Mexico, United States, 87102

Principal Investigator: Raymond Yau, MD

United States, New York

Montefiore Medical Center - Moses; Recruiting

Bronx, New York, United States, 10467-2401

Principal Investigator: Dimitrios Bliagos, MD

University at Buffalo/Kaleida Health; Recruiting

Buffalo, New York, United States, 14203

Principal Investigator: Vijay S. Iyer, MD

Northwell University Hospital; Recruiting

Manhasset, New York, United States, 11030

Principal Investigator: Perwaiz Meraj, MD

NYU Langone Health; Recruiting

New York, New York, United States, 10016

Principal Investigator: Craig Thompson, MD

Icahn School of Medicine at Mt. Sinai; Recruiting

New York, New York, United States, 10029

Principal Investigator: Samin Sharma, MD

Columbia University Medical Cenrer/NYPH; Recruiting

New York, New York, United States, 10032

Principal Investigator: Michael Collins, MD

St. Francis Hospital and Heart Center; Recruiting

Roslyn, New York, United States, 11576

Principal Investigator: Allen Jeremias, MD

Stony Brook University Hospital (SUNY); Recruiting

Stony Brook, New York, United States, 11794

Principal Investigator: Robert Pyo, MD

United States, North Carolina

Sanger Heart and Vascular Institute; Recruiting

Charlotte, North Carolina, United States, 28204

Principal Investigator: Nyal Borges, MD

North Carolina Heart and Vascular Research; Recruiting

Raleigh, North Carolina, United States, 27607

Principal Investigator: Robert Jobe, MD

Wake Forest University Health Sciences; Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator: Peter M Belford, MD

United States, Ohio

Linder Research Center (The Christ Hospital); Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator: Timothy Smith, MD

Cleveland Clinic Foundation; Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator: Jaikirshan Khatri, MD

United States, Oklahoma

University of Oklahoma Medical Center; Recruiting

Oklahoma City, Oklahoma, United States, 73104

Principal Investigator: Usman Baber, MD

United States, Oregon

Providence St. Vincent Medical Center; Recruiting

Portland, Oregon, United States, 97225

Principal Investigator: Jason Wollmuth, MD

Legacy Emanuel Hospital & Health Center; Recruiting

Portland, Oregon, United States, 97232

Principal Investigator: Amish Desai, MD

Oregon Health and Science University; Not yet recruiting

Portland, Oregon, United States, 97239

Contact: Harsh Golwala, MD golwala@ohsu.edu

Principal Investigator: Harsh Golwala, MD

United States, Pennsylvania

Lehigh Valley Health Network; Recruiting

Allentown, Pennsylvania, United States, 18103

Principal Investigator: Nainesh Patel, MD

Allegheny General Hospital; Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Principal Investigator: Mithun Chakravarthy, MD

WellSpan York Hospital; Recruiting

York, Pennsylvania, United States, 17403

Principal Investigator: Paul Tolerico, MD

United States, South Carolina

Greenville Hospital System; Recruiting

Greenville, South Carolina, United States, 29605

Principal Investigator: Jesse Jorgensen

United States, South Dakota

Monument Health Clinical Research; Recruiting

Rapid City, South Dakota, United States, 57701

Principal Investigator: Bhaskar Purushottam

United States, Tennessee

Wellmont Cardiology Services; Recruiting

Kingsport, Tennessee, United States, 37660

Principal Investigator: D. Christopher Metzger, MD

Parkwest Medical Center; Recruiting

Knoxville, Tennessee, United States, 37923

Principal Investigator: Ayaz Rahman, MD

Centennial Heart - Nashville; Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator: Andrew Goodman, MD

Ascension St. Thomas West; Recruiting

Nashville, Tennessee, United States, 37205

Principal Investigator: Elias Haddad, MD

Vanderbilt University Medical Center; Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator: Colin Barker, MD

United States, Texas

Presbyterian Hospital Dallas / Texas Health Physicians Group; Recruiting

Dallas, Texas, United States, 75231

Principal Investigator: James Park, MD

Medical City Fort Worth; Recruiting

Fort Worth, Texas, United States, 76104

Principal Investigator: Amir Malik, MD

University of Texas Medical Branch (UTMB) Galveston; Not yet recruiting

Galveston, Texas, United States, 77555

Principal Investigator: Syed Gilani, MD

HCA Houston Healthcare; Recruiting

Houston, Texas, United States, 77004

Principal Investigator: Pranav Loyalka, MD

Memorial Hermann Texas Medical Center (UT Health); Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Sachin Kumar, MD

Texas Heart Institute at Baylor St. Luke's Hospital; Not yet recruiting

Houston, Texas, United States, 77030

Principal Investigator: Samar Sheth, MD

Texas Cardiology Associates of Houston; Recruiting

Kingwood, Texas, United States, 77339

Principal Investigator: Robert Salazar, MD

Baylor Scott & White Heart - Plano; Recruiting

Plano, Texas, United States, 75093

Principal Investigator: Sameh Sayfo, MD

Methodist Hospital - San Antonio; Recruiting

San Antonio, Texas, United States, 78229

Principal Investigator: Nandish Thukral, MD

United States, Virginia

Sentara Norfolk Health System; Recruiting

Norfolk, Virginia, United States, 23507

Principal Investigator: Paul Lavigne, MD

VCU Medical Center; Not yet recruiting

Richmond, Virginia, United States, 23219

Principal Investigator: Lorenzo Azzalini, MD

Carilion Clinic; Recruiting

Roanoke, Virginia, United States, 24014

Principal Investigator: Chalak Berzingi, MD

United States, Washington

University Of Washington Medical Center; Recruiting

Seattle, Washington, United States, 98195

Principal Investigator: Kathleen Kearney, MD

United States, West Virginia

West Virginia University Hospital; Recruiting

Morgantown, West Virginia, United States, 26506

Principal Investigator: Ramesh Daggubati,, MD

United States, Wisconsin

Aurora St. Luke's Medical Center; Recruiting

Milwaukee, Wisconsin, United States, 53215

Principal Investigator: Lous Kostopoulos, MD

Medical College of Wisconsin; Recruiting

Milwaukee, Wisconsin, United States, 53226

Contact: Barbara Shimada-Krouwer, RN bshikrouwer@mcw.edu

Principal Investigator: Iyad Azzam, MD

Canada, Manitoba

St. Boniface Hospital; Not yet recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Principal Investigator: David Allen

Canada, Ontario

Toronto General Hospital; Not yet recruiting

Toronto, Ontario, Canada

Principal Investigator: Sanjog Kalra

Germany

Universitätsklinikum Erlangen; Recruiting

Erlangen, Bayern, Germany, 91054

Principal Investigator: Stephan Achenbach

Klinikum Karlsburg; Recruiting

Karlsburg, Mecklenburg-Vorpommern, Germany, 17495

Principal Investigator: Alkhlout

Universitätsklinikum Düsseldorf; Not yet recruiting

Düsseldorf, NRW, Germany, 40225

Principal Investigator: Ralf Westenfeld

Krankenhaus der Barmherzigen Brüder; Recruiting

Trier, Rheinland-Pfalz, Germany, 54292

Principal Investigator: Nikos Werner

University Hospital Aachen; Recruiting

Aachen, Germany, 52074

Principal Investigator: Jörg Schröder

Universitätsklinikum Freiburg, Universitäts-Herzzentrum; Recruiting

Bad Krozingen, Germany, 79189

Principal Investigator: Miroslaw Ferenc

Segeberger Kliniken GmbH; Not yet recruiting

Bad Segeberg, Germany, 23795

Principal Investigator: Abdelhakim Allali

Berlin CBF; Recruiting

Berlin, Germany, 12203

Principal Investigator: Carsten Skurk

CVK Berlin; Recruiting

Berlin, Germany, 13353

Principal Investigator: Mohammad Sherif

Klinikum Chemnitz gGmbH; Recruiting

Chemnitz, Germany, 09116

Principal Investigator: Karim Ibrahim

Herzzentrum Dresden GmbH; Recruiting

Dresden, Germany, 01307

Principal Investigator: Norman Mangner

Universitätsklinikum Essen AöR; Recruiting

Essen, Germany, 45147

Principal Investigator: Tienush Rassaf

Klinikum Friedrichshafen GmbH; Recruiting

Friedrichshafen, Germany, 88048

Principal Investigator: Jochen Wöhrle

Universitätsklinikum Gießen; Recruiting

Gießen, Germany, 35392

Principal Investigator: Holger Nef

St. Vinzenz-Hospital Gmbh Köln; Recruiting

Köln, Germany, 50733

Principal Investigator: Jan-Malte Sinning

Uniklinik Würzburg; Recruiting

Würzburg, Germany, 97080

Principal Investigator: Peter Nordbeck

Italy

Humanitas Clinical & Research Hospital; Not yet recruiting

Rozzano, Lombardy, Italy, 20089

Principal Investigator: Antonio Colombo

Policlinico Universitario Agostino Gemelli; Not yet recruiting

Rome, RM, Italy, 00168

Principal Investigator: Trani

Clinica Mediterranea; Not yet recruiting

Napoli, Italy, 80122

Principal Investigator: Briguori

Netherlands

Catharina Ziekenhuis Eindhoven; Recruiting

Eindhoven, North Brabant, Netherlands, 5623 EJ

Principal Investigator: Koen Teeuwen

LUMC-Leids Universitair Medisch Centrum; Not yet recruiting

Leiden, Zuid, Netherlands, 2333 ZA

Principal Investigator: José Montero-Cabezas

Switzerland

Istituto Cardiocentro Ticino; Recruiting

Lugano, Tessin, Switzerland, 6900

Principal Investigator: Marco Vaglimigli

Inselspital Bern; Recruiting

Bern, Switzerland, 3010

Principal Investigator: Lukas Hunziker

Luzerner Kantonsspital; Recruiting

Luzern, Switzerland, 6000

Principal Investigator: Florim Cuculi

United Kingdom

Royal Brompton Hospital; Not yet recruiting

London, United Kingdom

Principal Investigator: Jonathan Hill

Sponsors and Collaborators

Abiomed Inc.

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lusebrink E, Kellnar A, Krieg K, Binzenhofer L, Scherer C, Zimmer S, Schrage B, Fichtner S, Petzold T, Braun D, Peterss S, Brunner S, Hagl C, Westermann D, Hausleiter J, Massberg S, Thiele H, Schafer A, Orban M. Percutaneous Transvalvular Microaxial Flow Pump Support in Cardiology. Circulation. 2022 Apr 19;145(16):1254-1284. doi: 10.1161/CIRCULATIONAHA.121.058229. Epub 2022 Apr 18.

• Responsible Party: Abiomed Inc.
• ClinicalTrials.gov Identifier: NCT04763200
• Other Study ID Numbers: VV-TMF-18508
• First Posted: February 21, 2021
• Last Update Posted: January 2, 2024
• Last Verified: December 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Abiomed Inc.:

Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Myocardial Infarction; Anterior Wall Myocardial Infarction; Inferior Wall Myocardial Infarction

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ventricular Dysfunction; Ventricular Dysfunction, Left; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases