DurAVR™ THV EU-EFS

NCT ID: NCT06510855

Last Updated: 2024-07-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2030-10-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Severe Aortic Stenosis (sAS) Cohort

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

Group Type: EXPERIMENTAL

DurAVR™ THV System

Intervention Type: DEVICE

DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

Failed Surgical Aortic Bioprosthetic Valve (FAV) Cohort

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

Group Type: EXPERIMENTAL

DurAVR™ THV System

Intervention Type: DEVICE

DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

Interventions

DurAVR™ THV System

DurAVR™ THV System - Transcatheter Aortic Valve Implantation (TAVI) Procedure

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anteris Technologies Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Silvia Zinicchino, MS BME, MBA

Role: CONTACT

szinicchino@anteristech.com

+41793252977

Ioana Ghiu, MD

Role: CONTACT

ighiu@anteristech.com

+106122196032

Other Identifiers

SP0082

Identifier Type: -

Identifier Source: org_study_id