Status:
NOT_YET_RECRUITING
DurAVR™ THV EU-EFS
Lead Sponsor:
Anteris Technologies Ltd.
Conditions:
Symptomatic Aortic Stenosis
Severe Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic s...
Detailed Description
The DurAVR™ THV System is a novel balloon-expandable single-piece transcatheter aortic valve. The study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe de...
Eligibility Criteria
Inclusion
- Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
- Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
- Eligible for transfemoral 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
- Anatomy precluding safe placement of DurAVR™ THV
- Pre-existing prosthetic mitral or tricuspid valve
- Unicuspid, bicuspid or non-calcified aortic valve
- 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
- Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
- Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
- Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
- GI bleeding within the past 3 months
- Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
- Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06510855
Start Date
October 1 2024
End Date
October 1 2030
Last Update
July 23 2024
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