Clinical trial NCT05182307: DurAVR™ THV System: First-In-Human Study
Official title: Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Symptomatic Aortic Stenosis
Severe Aortic Valve Stenosis
Aortic Valve Calcification
Keywords: TAVI
TAVR
Transcatheter Aortic Valve Implantation
Transcatheter valve
Lead sponsor: Anteris Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility 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.

Primary outcomes:
measure: DurAVR™ prosthetic heart valve implant
timeFrame: Immediate post procedure
measure: Hemodynamic performance
timeFrame: Immediate post procedure
measure: All-cause mortality
timeFrame: 30 days
measure: All-cause mortality
timeFrame: 1 year
measure: Myocardial infarction
timeFrame: 30 days
measure: Myocardial infarction
timeFrame: 1 year
measure: Stroke
timeFrame: 30 days
measure: Stroke
timeFrame: 1 year
measure: Life-threatening bleeding
timeFrame: 30 days
measure: Life-threatening bleeding
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: DurAVR™ THV System ease of use
timeFrame: Intra-operative
measure: Adverse Events
timeFrame: Throughout the entire study, up to 1 year.
Locations:
city: Tbilisi
country: Georgia
facility: Tbilisi Heart and Vascular Clinic Ltd
Study officials:
affiliation: Anteris Technologies
name: Chris Meduri, MD
role: STUDY_DIRECTOR
References: