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Trial record 2 of 27 for:    Evolut TAVR
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Medtronic Evolut™ EXPAND TAVR I Feasibility Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04639258
Recruitment Status : Terminated (Reevaluation of clinical strategy in this patient population led to a business decision to discontinue the study. Discontinuation is not due to any patient safety, patient welfare, or quality issues.)
First Posted : November 20, 2020
Results First Posted : January 10, 2024
Last Update Posted : January 10, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiovascular

Study Description
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Brief Summary:
The purpose of the study is to obtain safety and effectiveness data of the Medtronic Evolut™ PRO+ TAVR System for the treatment of severe, asymptomatic aortic stenosis.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Medtronic Evolut™ PRO+ System Not Applicable

Detailed Description:

Single-arm, descriptive, multi-center, international

All subjects will be treated with a Medtronic Evolut™ PRO+ TAVR System. Subject follow-ups will be conducted at pre and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medtronic Evolut™ EXPAND TAVR I Feasibility Study
Actual Study Start Date : May 28, 2021
Actual Primary Completion Date : June 7, 2022
Actual Study Completion Date : June 7, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Medtronic Evolut™ PRO+ System
All study subjects will be treated with the Medtronic Evolut™ PRO+ TAVR System.
 Device: Medtronic Evolut™ PRO+ System
TAVR treatment with Medtronic Evolut™ PRO+ System


Outcome Measures
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Primary Outcome Measures :
  1. All-cause and Cardiovascular Mortality [ Time Frame: 30 days ]
    Rate of all-cause and cardiovascular mortality

  2. All-cause and Cardiovascular Mortality [ Time Frame: 6 months ]
    Rate of all-cause and cardiovascular mortality

  3. All Stroke (Disabling and Non-disabling) [ Time Frame: 30 days ]
    Rate of disabling and non-disabling stroke

  4. All Stroke (Disabling and Non-disabling) [ Time Frame: 6 months ]
    Rate of disabling and non-disabling stroke

  5. Myocardial Infarction (Periprocedural and Spontaneous) [ Time Frame: 30 days ]
    Rate of periprocedural and spontaneous myocardial infarction

  6. Myocardial Infarction (Periprocedural and Spontaneous) [ Time Frame: 6 months ]
    Rate of periprocedural and spontaneous myocardial infarction

  7. Acute Kidney Injury [ Time Frame: 30 days ]
    Rate of acute kidney injury

  8. Acute Kidney Injury [ Time Frame: 6 months ]
    Rate of acute kidney injury

  9. Major Vascular Complications [ Time Frame: 30 days ]
    Rate of major vascular complications

  10. Major Vascular Complications [ Time Frame: 6 months ]
    Rate of major vascular complications

  11. Life-threatening Bleed [ Time Frame: 30 days ]
    Rate of life-threatening (or disabling) bleed

  12. Life-threatening Bleed [ Time Frame: 6 months ]
    Rate of life-threatening (or disabling) bleed

  13. New Permanent Pacemaker Implantation (PPI) [ Time Frame: 30 days ]
    Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

  14. New Permanent Pacemaker Implantation (PPI) [ Time Frame: 6 months ]
    Rate of new permanent pacemaker implantation (excludes patients with pre-existing pacemakers at baseline)

  15. New Intraventricular Conduction Delays [ Time Frame: 30 days ]
    Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

  16. New Intraventricular Conduction Delays [ Time Frame: 6 months ]
    Rate of new intraventricular conduction delays (excludes patients with intraventricular conduction delays at baseline)

  17. New-onset Atrial Fibrillation [ Time Frame: 30 days ]
    Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

  18. New-onset Atrial Fibrillation [ Time Frame: 6 months ]
    Rate of new-onset atrial fibrillation (excludes patients with atrial fibrillation at baseline)

  19. Valve-related Dysfunction Requiring Repeat Procedure [ Time Frame: 30 days ]
    Rate of valve-related dysfunction requiring repeat procedure

  20. Valve-related Dysfunction Requiring Repeat Procedure [ Time Frame: 6 months ]
    Rate of valve-related dysfunction requiring repeat procedure

  21. Device Success (VARC-2) [ Time Frame: Discharge (12 hours to 7 days post-procedure) ]
    The VARC-2 definition of device success is absence of procedural mortality, correct positioning of a single prosthetic heart valve into the proper anatomical location, intended performance of the prosthetic heart valve, defined as the absence of patient-prosthesis-mismatch and mean aortic valve gradient less than 20 mmHg (or peak velocity <3 m/sec), and absence of moderate or severe prosthetic valve regurgitation

  22. Cardiovascular and Heart Failure Hospitalizations [ Time Frame: 30 days ]
    Rate of cardiovascular and heart failure hospitalizations

  23. Cardiovascular and Heart Failure Hospitalizations [ Time Frame: 6 months ]
    Rate of cardiovascular and heart failure hospitalizations

  24. Heart Failure Events [ Time Frame: 30 days ]
    Rate of heart failure events

  25. Heart Failure Events [ Time Frame: 6 months ]
    Rate of heart failure events

  26. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography [ Time Frame: Discharge (12 hours to 7 days post-procedure) ]
    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  27. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  28. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography [ Time Frame: 6 months ]
    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  29. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography [ Time Frame: Discharge (12 hours to 7 days post-procedure) ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  30. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography [ Time Frame: 30 days ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  31. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography [ Time Frame: 6 months ]
    Change in hemodynamic performance metrics by Doppler echocardiography measured by effective orifice area.

  32. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography [ Time Frame: Discharge (12 hours to 7 days post-procedure) ]
    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

  33. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

  34. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography [ Time Frame: 6 months ]
    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular regurgitation by Doppler echocardiography

  35. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography [ Time Frame: Discharge (12 hours to 7 days post-procedure) ]
    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

  36. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography [ Time Frame: 30 days ]
    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

  37. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography [ Time Frame: 6 months ]
    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

  38. Change From Baseline in New York Heart Association (NYHA) Functional Classification [ Time Frame: 30 days and 6 months ]

    Reporting of NYHA classification change from baseline to 30 days and 6 months

    NYHA Classification criteria:

    Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

    Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

    Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

    Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.


  39. Change From Baseline in Six-minute Walk Test (6MWT) [ Time Frame: 6 months ]
    Reporting change from baseline in distance walked during 6MWT

  40. Change From Baseline in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 30 days and 6 months ]
    KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  41. Change From Baseline in Left Ventricular Ejection Fraction (LVEF) [ Time Frame: 6 months ]
    Reporting of change in left ventricular ejection fraction (LVEF) from baseline by echocardiography

  42. Change From Baseline in Global Longitudinal Strain (GLS) [ Time Frame: 6 months ]
    Reporting of change in GLS from baseline by echocardiography

  43. Change From Baseline in Left Ventricular Filling Pressure (E:e') [ Time Frame: 6 months ]
    Reporting of change in left ventricular filling pressure (E:e') from baseline by echocardiography

  44. Change From Baseline in Stroke Volume Index (SVI) [ Time Frame: 6 months ]
    Reporting of change in stroke volume index (SVI) from baseline by echocardiography

  45. Change From Baseline in NT-pro B-type Natriuretic Peptide (NT-proBNP) [ Time Frame: 6 months ]
    Reporting of change in NT-pro B-type natriuretic peptide (NT-proBNP) from baseline


Other Outcome Measures:
  1. All-cause and Cardiovascular Mortality [ Time Frame: Annually through 5 years ]
    Rate of all-cause and cardiovascular mortality

  2. All Stroke (Disabling and Non-disabling) [ Time Frame: Annually through 5 years ]
    Rate of disabling and non-disabling strokes

  3. Cardiovascular and Heart Failure Hospitalizations [ Time Frame: Annually through 5 years ]
    Rate of cardiovascular and heart failure hospitalizations

  4. Heart Failure Events [ Time Frame: Annually through 5 years ]
    Rate of heart failure events

  5. New York Heart Association (NYHA) Functional Classification [ Time Frame: 30 days, 6 months, and annually through 5 years ]
    Reporting NYHA functional classification by timepoint following attempted procedure

  6. Change From Baseline in New York Heart Association (NYHA) Functional Classification [ Time Frame: Annually through 5 years ]

    Reporting of NYHA classification change from baseline to 30 days and 6 months

    NYHA Classification criteria:

    Class I: Subjects with cardiac disease but without resulting limitations of physical activity.

    Class I: Subjects with cardiac disease resulting in slight limitation of physical activity.

    Class III: Subjects with cardiac disease resulting in marked limitation of physical activity.

    Class IV: Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort.


  7. Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Annually through 5 years ]
    KCCQ quantifies physical function, symptoms, social function, self-efficiency, knowledge, and quality of life. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.

  8. Hemodynamic Performance Metrics (Mean Aortic Gradient) by Doppler Echocardiography [ Time Frame: Annually through 5 years ]
    Reporting of prosthetic valve hemodynamic performance by transvalvular mean aortic gradient

  9. Hemodynamic Performance Metrics (Effective Orifice Area) by Doppler Echocardiography [ Time Frame: Annually through 5 years ]
    Reporting of prosthetic valve hemodynamic performance by effective orifice area (EOA)

  10. Hemodynamic Performance Metrics (Degree of Total, Para, and Transvalvular Prosthetic Regurgitation) by Doppler Echocardiography [ Time Frame: Annually through 5 years ]
    Reporting of prosthetic valve hemodynamic performance by degree of total, para, and transvalvular prosthetic regurgitation by Doppler echocardiography

  11. Hemodynamic Performance Metrics (Incidence of Moderate and Severe Patient-prosthesis Mismatch) by Doppler Echocardiography [ Time Frame: Annually through 5 years ]
    Reporting of prosthetic valve hemodynamic performance by incidence of moderate and severe patient-prosthesis mismatch by Doppler echocardiography

  12. Prosthetic Valve Thrombosis [ Time Frame: 30 days, 6 months, and annually through 5 years ]
    Rate of prosthetic valve thrombosis

  13. Prosthetic Valve Endocarditis [ Time Frame: 30 days, 6 months, and annually through 5 years ]
    Rate of prosthetic valve endocarditis

  14. Bioprosthetic Valve Dysfunction (BVD) [ Time Frame: 30 days, 6 months, and annually through 5 years ]
    Rate of bioprosthetic valve dysfunction (BVD)

  15. Bioprosthetic Valve Failure (BVF) [ Time Frame: 30 days, 6 months, and annually through 5 years ]
    Rate of bioprosthetic valve failure (BVF)

  16. Valve-related Dysfunction Requiring Repeat Procedure [ Time Frame: Annually through 5 years ]
    Rate of valve-related dysfunction requiring repeat procedure


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Severe aortic stenosis, defined as: Aortic valve area ≤ 1.0 cm^2, or aortic valve area index ≤ 0.6 cm^2/m^2, and mean gradient ≥ 40 mmHg or Vmax ≥ 4.0 m/sec

  • Subject denies symptoms attributable to aortic stenosis, including but not limited to:

    • Dyspnea on rest or exertion
    • Angina
    • Syncope in the absence of another identifiable cause
    • Fatigue
    • Left Ventricular Ejection Fraction (LVEF) >50%

Key Exclusion Criteria:

  • Age <65 years
  • Class I indication for cardiac surgery
  • Bicuspid, unicuspid, or quadricuspid aortic valve
  • In need of and suitable for coronary revascularization
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639258


Locations
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United States, California
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States, 91360
United States, New York
Northwell Health
Manhasset, New York, United States, 11030-3816
United States, Pennsylvania
UPMC Pinnacle Harrisburg Campus
Wormleysburg, Pennsylvania, United States, 17043
United States, Wisconsin
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Australia
The Alfred Hospital
Melbourne, Australia
Canada
IUCPQ
Quebec, Canada, G1V 4G5
Israel
Rabin Medical Center
Petah Tikva, Israel, 49100
New Zealand
Waikato Hospital
Hamilton, New Zealand
Sponsors and Collaborators
Medtronic Cardiovascular
Investigators
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Principal Investigator: Paul Sorajja, MD Allina Health System
Principal Investigator: Josep Rodes-Cabau, MD Fondation IUCPQ
  Study Documents (Full-Text)

Documents provided by Medtronic Cardiovascular:
Study Protocol  [PDF] March 9, 2021
Statistical Analysis Plan  [PDF] May 11, 2021

More Information
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Responsible Party: Medtronic Cardiovascular
ClinicalTrials.gov Identifier: NCT04639258    
Other Study ID Numbers: D00266108
First Posted: November 20, 2020    Key Record Dates
Results First Posted: January 10, 2024
Last Update Posted: January 10, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases
 Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction