Trials / Recruiting
RecruitingNCT06342635
Hydra Single-centre Experience - Copenhagen, Denmark
Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Sahajanand Medical Technologies Limited · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hydra Transcatheter Aortic Valve (THV) Series | The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position. |
Timeline
- Start date
- 2024-06-18
- Primary completion
- 2025-09-30
- Completion
- 2026-10-31
- First posted
- 2024-04-02
- Last updated
- 2024-07-05
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT06342635. Inclusion in this directory is not an endorsement.