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Protect the Head to Head Study (ProtectH2H)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05684146
Recruitment Status : Recruiting
First Posted : January 13, 2023
Last Update Posted : May 19, 2023
Sponsor:
Information provided by (Responsible Party):
Emboline

Study Description
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Brief Summary:
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study

Condition or disease Intervention/treatment Phase
Embolism Device: Emboliner Embolic Protection Device: Sentinel Cerebral Protection Phase 2

Detailed Description:
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study to demonstrate safety and effectiveness based on non-inferiority of the study device (Emboliner EPD) compared to the control device (Sentinel CPS) in terms of a 30-day composite major adverse cardiac and cerebrovascular events (MACCE) rate - defined as all death, stroke and Stage 3 acute kidney injury - evaluated on a per-patient basis, post-TAVR procedures
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: G4: Model Description* Subjects will be randomized (1:1) to either the Emboliner (ARM 1) or Sentinel CPS (ARM 2). Device randomization will be stratified by (a) site and (b) TAVR device type (Edwards or Medtronic) to ensure that each study arm represents an equivalent patient population.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protect the Head to Head: A Safety and Efficacy Assessment of the Emboliner Embolic Protection Device
Actual Study Start Date : May 4, 2023
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Emboliner Embolic Protection Device
Emboliner embolic protection device to be used during TAVR procedures for stroke prevention
 Device: Emboliner Embolic Protection
Emboliner Embolic Protection Device will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Other Name: Embolic protection
Active Comparator: Sentinel Cerebral Protection System
Sentinel Cerebral Protection System to be used during TAVR procedures for stroke prevention
 Device: Sentinel Cerebral Protection
The Sentinel Cerebral Protection System will be used to capture and remove embolic material during transcatheter aortic valve replacement (TAVR) interventions
Other Name: Embolic protection


Outcome Measures
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Primary Outcome Measures :
  1. Non-inferiority [ Time Frame: Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate. ]

    Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate.

    K4: Description Non-inferiority of 30-day Emboliner device MACCE patient incidence rate compared to the Sentinel device patient incidence rate.

    30 Days



Secondary Outcome Measures :
  1. Non-inferiority VARC-2 [ Time Frame: 30 Days ]
    Non-inferiority of 30-day Emboliner device VARC 2-defined stroke incidence rate compared to the Sentinel device incidence rate.

  2. Debris Capture [ Time Frame: 30 Days ]
    The count (by number of particles >150 microns) of debris capture using the Emboliner device will be compared to the count of debris captured by the Sentinel device.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Eligible for treatment for symptomatic severe aortic stenosis using a FDA-approved TAVR valve according to current guidelines
  2. Consented to the TAVR procedure
  3. Subject and physician agree that subject will return for required post-procedure follow-up
  4. Willing to participate in study and provide signed EC/IRB-approved informed consent
  5. Eighteen (18) years or older at the time of consent

Exclusion Criteria:

  1. Not undergoing a planned TAVR via transfemoral access
  2. Severe allergy or hypersensitivity to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, nitinol, and/or contrast agents that cannot be pre-medicated
  3. Uncorrected bleeding disorder
  4. Hypercoagulation status that cannot be corrected by additional peri-procedural heparin
  5. Myocardial infarction (MI) diagnosis <30 days prior to study procedure
  6. History of substance abuse that may cause non-compliance with the protocol or confound the data interpretation
  7. Cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension (systolic blood pressure <90 mmHg) at time of screening
  8. History of a stroke < 180 days prior to study procedure
  9. Active peptic ulcer or history of upper gastrointestinal (GI) bleeding < 90 days prior to study procedure
  10. Congenital unicuspid aortic valve
  11. Porcelain aorta, asymmetrical or sharp aortic calcifications, severe aortic tortuosity, shaggy aorta or mobile atheroma in the arch
  12. Pre-existing prosthetic heart valve in any position, prosthetic ring, or severe (greater than 3+) mitral insufficiency
  13. Current leukopenia, acute anemia, thrombocytopenia, history of chronic bleeding diathesis, or coagulopathy that requires treatment
  14. Hypertrophic cardiomyopathy with or without obstruction
  15. Left ventricular ejection fraction (LVEF) ≤20%
  16. Echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation
  17. Active infection or endocarditis
  18. Neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults
  19. Carotid stent placement or endarterectomy performed <180 days prior to study procedure.
  20. Severe renal insufficiency (creatinine >3.0 mg/dL or GFR <30 mL/min) or patient on dialysis
  21. Planned treatment with another investigational device or procedure during the study period
  22. Balloon valvuloplasty (BAV) within 30 days of the procedure
  23. Any planned surgical or interventional cardiac procedure (e.g., concurrent coronary revascularization or AF ablation) during the TAVR procedure, within 30 days before or after the TAVR procedure
  24. Emergency surgery for any reason
  25. Pregnancy, lactation or intent to become pregnant during study participation
  26. Unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment
  27. Investigator considers participation in the study not to be in the subject's best interest
  28. Dementia or any other cognitive deficit that results in inability to provide informed consent or comply with the study protocol
  29. Presence of hemodialysis shunt, graft, or arterio-venous fistula involving access vasculature
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): NCT05684146


Contacts
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Contact: Laura A Brenton +1 313 919 8044 lbrenton@emboline.com
Contact: Duda Markovic +1 858 220 2777 dmarkovic@emboline.com

Locations
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United States, New York
NewYork-Presbyterian/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
United States, Oklahoma
Oklahoma Heart Institute Recruiting
Tulsa, Oklahoma, United States, 74104
Sponsors and Collaborators
Emboline
Investigators
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Study Director: Laura A Brenton Emboline, Inc.
More Information
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Responsible Party: Emboline
ClinicalTrials.gov Identifier: NCT05684146    
Other Study ID Numbers: TP-0527
First Posted: January 13, 2023    Key Record Dates
Last Update Posted: May 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Emboline:
MACCE
TAVR
Embolism
Additional relevant MeSH terms:
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Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases