Clinical trial NCT06510855: DurAVR™ THV EU-EFS
Official title: DurAVR™ THV System: European Early Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Symptomatic Aortic Stenosis
Severe Aortic Valve Stenosis
Aortic Valve Calcification
Aortic Valve Failure
Aortic Valve Disease
Keywords: Transcatheter Aortic Valve Implantation (TAVI)
Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter Valve
Valve-in-Valve
Aortic Valve Disease
Lead sponsor: Anteris Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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 stenosis or failed surgical aortic bioprosthetic valves.

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 degeneration of surgically implanted aortic bioprosthetic valves, with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Subjects will be consented for follow-up to 5 years.

Eligibility criteria: Inclusion Criteria:

1. Symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older.
2. Requires aortic valve replacement and is indicated for TAVR as determined by the Heart Team
3. Eligible for transfemoral delivery of the DurAVR™ THV
4. Anatomy appropriate to accommodate safe placement of DurAVR™ THV
5. Understands the study requirements and the treatment procedures and provides written informed consent
6. Subject agrees to complete all required scheduled follow-up visits.

Exclusion Criteria:

1. Anatomy precluding safe placement of DurAVR™ THV
2. Pre-existing prosthetic mitral or tricuspid valve
3. Unicuspid, bicuspid or non-calcified aortic valve
4. Severe mitral or severe tricuspid regurgitation requiring intervention
5. Moderate to severe mitral stenosis
6. Hypertrophic obstructive cardiomyopathy
7. Echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment
8. Evidence of an acute myocardial infarction ≤ 30 days before the intended treatment
9. Any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure
10. Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
11. End-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min
12. GI bleeding within the past 3 months
13. Ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months
14. Life expectancy \< 12 months due to associated non-cardiac co-morbid conditions

Primary outcomes:
measure: All-cause mortality or disabling stroke
timeFrame: 30 Days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 Days
measure: Disabling stroke
timeFrame: 30 Days
measure: Life-threatening bleeding
timeFrame: 30 Days
measure: Major vascular, access-related, or cardiac structural complication
timeFrame: 30 Days
measure: Acute kidney injury stage 3 or 4
timeFrame: 30 Days
measure: Moderate or severe aortic regurgitation
timeFrame: 30 Days
measure: New permanent pacemaker due to procedure related conduction abnormalities
timeFrame: 30 Days
measure: Surgery or intervention related to the device, including aortic valve reintervention
timeFrame: 30 Days
Other outcomes:
Locations:
Study officials:
References: