Trials / Not Yet Recruiting
Not Yet RecruitingNCT06375590
NavIIcusp: Bicuspid Aortic Valve Stenosis With Navitor Platform International Experience
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Didier TCHETCHE · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this prospective registry is to evaluate the clinical impact of the new Navitor prosthesis (Abbott, Minneapolis, MN, USA) in BAV and evaluate both the main sizing methods (the classical annular or the supra-annular with ICD measurement at 4 mm above the virtual basal ring).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Aortic Valve Implantation | Transcatheter treatment of bicuspid stenosis with the Navitor platform |
Timeline
- Start date
- 2024-05-01
- Primary completion
- 2025-05-01
- Completion
- 2026-05-01
- First posted
- 2024-04-19
- Last updated
- 2024-04-19
Locations
1 site across 1 country: France
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06375590. Inclusion in this directory is not an endorsement.