UnknownNot Applicable

DurAVR™ THV System: First-In-Human Study

Georgia50 participantsStarted 2021-11-15

Plain-language summary

A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Symptomatic, severe aortic stenosis
✓. Eligible for 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 criteria

✕. Anatomy precluding safe placement of DurAVR™ THV
✕. Pre-existing prosthetic heart valve in any position
✕. Unicuspid or bicuspid aortic valve
✕. Severe aortic regurgitation
✕. 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

What they're measuring

DurAVR™ prosthetic heart valve implant

Timeframe: Immediate post procedure

Hemodynamic performance

Timeframe: Immediate post procedure

All-cause mortality

Timeframe: 30 days

All-cause mortality

Timeframe: 1 year

Myocardial infarction

Timeframe: 30 days

Myocardial infarction

Timeframe: 1 year

Stroke

Timeframe: 30 days

Stroke

Timeframe: 1 year

Life-threatening bleeding

Timeframe: 30 days

Trial details

NCT IDNCT05182307

SponsorAnteris Technologies Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01

View on ClinicalTrials.gov More Symptomatic Aortic Stenosis trials