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DurAVR™ THV System: First-In-Human 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: NCT05182307
Recruitment Status : Active, not recruiting
First Posted : January 10, 2022
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Anteris Technologies Ltd.

Study Description
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Brief Summary:
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Condition or disease Intervention/treatment Phase
Symptomatic Aortic Stenosis Severe Aortic Valve Stenosis Aortic Valve Calcification Device: DurAVR™ THV System Not Applicable

Detailed Description:

The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve.

The study will enroll up to 25 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
DurAVR™ THV System
 Device: DurAVR™ THV System
Transcatheter Aortic Valve Implantation (TAVI) Procedure


Outcome Measures
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Primary Outcome Measures :
  1. DurAVR™ prosthetic heart valve implant [ Time Frame: Immediate post procedure ]
    Number of subjects for which a single DurAVR™ prosthetic heart valve was correctly positioned into the proper anatomical location

  2. Hemodynamic performance [ Time Frame: Immediate post procedure ]
    Effective Orifice Area (EOA), Mean gradient, Aortic Regurgitation, Paravalvular Leak (PVL), Doppler Velocity Index (DVI)

  3. All-cause mortality [ Time Frame: 30 days ]
    All-cause mortality

  4. All-cause mortality [ Time Frame: 1 year ]
    All-cause mortality

  5. Myocardial infarction [ Time Frame: 30 days ]
    Myocardial infarction

  6. Myocardial infarction [ Time Frame: 1 year ]
    Myocardial infarction

  7. Stroke [ Time Frame: 30 days ]
    Disabling Stroke (VARC-3 Guidelines)

  8. Stroke [ Time Frame: 1 year ]
    Disabling Stroke (VARC-3 Guidelines)

  9. Life-threatening bleeding [ Time Frame: 30 days ]
    Life-threatening bleeding (VARC-3 Guidelines)

  10. Life-threatening bleeding [ Time Frame: 1 year ]
    Life-threatening bleeding (VARC-3 Guidelines)


Other Outcome Measures:
  1. DurAVR™ THV System ease of use [ Time Frame: Intra-operative ]
    DurAVR™ THV System ease of use (Questionnaire)

  2. Adverse Events [ Time Frame: Throughout the entire study, up to 1 year. ]
    VARC-3 defined adverse events


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Symptomatic, severe aortic stenosis
  2. Eligible for delivery of the DurAVR™ THV
  3. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
  4. Understands the study requirements and the treatment procedures and provides written informed consent.
  5. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

Anatomical

  1. Anatomy precluding safe placement of DurAVR™ THV
  2. Pre-existing prosthetic heart valve in any position
  3. Unicuspid or bicuspid aortic valve
  4. Severe aortic regurgitation
  5. Severe mitral or severe tricuspid regurgitation requiring intervention
  6. Moderate to severe mitral stenosis
  7. Hypertrophic obstructive cardiomyopathy
  8. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
  9. Severe basal septal hypertrophy with outflow gradient Clinical
  10. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
  11. Determined inoperable/ineligible for surgery by the Heart Team
  12. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
  13. Blood dyscrasias as defined: leukopenia (WBC < 1000mm3), thrombocytopenia (platelet count < 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
  14. Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
  15. Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
  16. Need for emergency surgery for any reason
  17. Ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40% as measured by resting echocardiogram
  18. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  19. Symptomatic carotid or vertebral artery disease
  20. End stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
  21. GI bleeding within the past 3 months
  22. A known hypersensitivity or contraindication to any of the following which cannot be adequately pre-medicated: aspirin, heparin, nitinol (titanium or nickel), ticlopidine and clopidogrel, contrast media
  23. Ongoing sepsis, including active endocarditis
  24. Subject refuses a blood transfusion
  25. Life expectancy < 12 months due to associated non-cardiac co-morbid conditions
  26. Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
  27. Severe dementia (resulting in either inability to provide informed consent for the trial/procedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)
  28. Currently participating in an investigational drug or another investigational device trial
  29. Subject belongs to a vulnerable population.
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): NCT05182307


Locations
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Georgia
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, Georgia
Sponsors and Collaborators
Anteris Technologies Ltd.
Investigators
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Study Director: Chris Meduri, MD Anteris Technologies
More Information
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Responsible Party: Anteris Technologies Ltd.
ClinicalTrials.gov Identifier: NCT05182307    
Other Study ID Numbers: SP0011
First Posted: January 10, 2022    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
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: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Anteris Technologies Ltd.:
TAVI
TAVR
Transcatheter Aortic Valve Implantation
Transcatheter valve
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease
 Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction