DurAVR™ THV EU-EFS

Not Applicable

Not yet recruiting

• Conditions: Symptomatic Aortic Stenosis; Aortic Valve Disease; Severe Aortic Valve Stenosis; Aortic Valve Failure; Aortic Valve Calcification
• Interventions: Device: DurAVR™ THV System

• Registration Number: NCT06510855
• Lead Sponsor: Anteris Technologies Ltd.

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-23
• Study Start: 2024-10
• Primary Completion: 2025-06
• Study Completion: 2030-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Severe Aortic Stenosis (sAS) Cohort	DurAVR™ THV System	Subjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.
Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort	DurAVR™ THV System	Subjects with severe degeneration of surgically implanted aortic bioprosthetic valves with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Primary Outcome Measures

Name	Time	Method
All-cause mortality or disabling stroke	30 Days	Mortality would be reported as rate of death/mortality at 30 days. Disabling stroke would be reported according to VARC-3 Guidelines

Secondary Outcome Measures

Name	Time	Method
Disabling stroke	30 Days	Disabling stroke would be reported according to VARC-3 Guidelines
All-cause mortality	30 Days	Mortality would be reported as rate of death/mortality at 30 days.
Life-threatening bleeding	30 Days	Life-threatening bleeding according to VARC-3 Guidelines
New permanent pacemaker due to procedure related conduction abnormalities	30 Days	Rate of pacemaker interventions in subjects experiencing conduction abnormalities (sAS cohort only)
Surgery or intervention related to the device, including aortic valve reintervention	30 Days	Device related interventions
Major vascular, access-related, or cardiac structural complication	30 Days	Major vascular, access-related, or cardiac structural complication according to VARC-3 Guidelines
Moderate or severe aortic regurgitation	30 Days	Aortic regurgitation according to VARC-3 Guidelines
Acute kidney injury stage 3 or 4	30 Days	AKI according to VARC-3 Guidelines