DurAVR™ THV EU-EFS

Anteris

Status: Not yet enrolling

Conditions: Severe Aortic Valve Stenosis; Aortic Valve Disease; Symptomatic Aortic Stenosis; Aortic Valve Failure; Aortic Valve Calcification

Treatments: Device: DurAVR™ THV System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06510855

SP0082

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Severe Aortic Stenosis (sAS) Cohort

Experimental group

Description:

Subjects with symptomatic severe native aortic stenosis with a Heart Team determination of eligibility for delivery of the DurAVR™ THV prosthesis.

Treatment:

Device: DurAVR™ THV System

Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort

Experimental group

Description:

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

Treatment:

Device: DurAVR™ THV System