Trials / Active Not Recruiting
Active Not RecruitingNCT05712161
Use of DurAVR™ THV System in Subjects With Severe Aortic Stenosis: Early Feasibility Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Anteris Technologies Ltd. · Industry
- Sex
- All
- Age
- 65 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
Detailed description
The primary objective is to assess the acute and long-term safety and feasibility of the DurAVR™ device in adult subjects with symptomatic, severe native aortic stenosis eligible for the transcatheter aortic valve replacement as assessed by the Heart Team at the enrolling institutions. This is a prospective, non-randomized, single-arm, multi-center Study. Subjects will be consented for follow-up to 10 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | DurAVRTM THV System | The DurAVR™ Transcatheter Heart Valve (THV) is a balloon expandable transcatheter aortic valve |
Timeline
- Start date
- 2023-08-07
- Primary completion
- 2023-12-29
- Completion
- 2033-12-01
- First posted
- 2023-02-03
- Last updated
- 2026-04-08
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05712161. Inclusion in this directory is not an endorsement.