Trials / Unknown
UnknownNCT05182307
DurAVR™ THV System: First-In-Human Study
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: First In Human Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Anteris Technologies Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
The DurAVR™ THV System is a novel balloon-expandable single-piece 3D transcatheter aortic valve. The study will enroll up to 25 subjects suffering from severe, symptomatic aortic stenosis as determined by a Heart Team. Subjects will be consented for follow-up to 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DurAVR™ THV System | Transcatheter Aortic Valve Implantation (TAVI) Procedure |
Timeline
- Start date
- 2021-11-15
- Primary completion
- 2025-01-01
- Completion
- 2025-01-01
- First posted
- 2022-01-10
- Last updated
- 2024-01-31
Locations
1 site across 1 country: Georgia
Source: ClinicalTrials.gov record NCT05182307. Inclusion in this directory is not an endorsement.