Status:
ACTIVE_NOT_RECRUITING
DurAVR™ THV System: First-In-Human Study
Lead Sponsor:
Anteris Technologies Ltd.
Conditions:
Symptomatic Aortic Stenosis
Severe Aortic Valve Stenosis
Eligibility:
All Genders
Phase:
NA
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 s...
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 determin...
Eligibility Criteria
Inclusion
- Symptomatic, severe aortic stenosis
- Eligible for delivery of the DurAVR™ THV
- Anatomy appropriate to accommodate safe placement of DurAVR™ THV
- Understands the study requirements and the treatment procedures and provides written informed consent.
- Subject agrees to complete all required scheduled follow-up visits.
Exclusion
- Anatomical
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic heart valve in any position
- Unicuspid or bicuspid aortic valve
- Severe aortic regurgitation
- Severe mitral or severe tricuspid regurgitation requiring intervention
- Moderate to severe mitral stenosis
- Hypertrophic obstructive cardiomyopathy
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
- Severe basal septal hypertrophy with outflow gradient Clinical
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
- Determined inoperable/ineligible for surgery by the Heart Team
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- Blood dyscrasias as defined: leukopenia (WBC \< 1000mm3), thrombocytopenia (platelet count \< 50,000 cells/mm3), history of bleeding diathesis or coagulopathy, or hypercoagulable states
- Untreated clinically significant Coronary Artery Disease (CAD) requiring revascularization
- Cardiogenic shock manifested by low cardiac output, vasopressor dependence, or mechanical hemodynamic support
- Need for emergency surgery for any reason
- Ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40% as measured by resting echocardiogram
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Symptomatic carotid or vertebral artery disease
- End stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
- GI bleeding within the past 3 months
- 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
- Ongoing sepsis, including active endocarditis
- Subject refuses a blood transfusion
- Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions
- Other medical, social, or psychological conditions that in the opinion of an Investigator precludes the subject from appropriate consent
- 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)
- Currently participating in an investigational drug or another investigational device trial
- Subject belongs to a vulnerable population.
Key Trial Info
Start Date :
November 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05182307
Start Date
November 15 2021
End Date
January 1 2025
Last Update
January 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tbilisi Heart and Vascular Clinic Ltd
Tbilisi, Georgia