Trials / Recruiting
RecruitingNCT05797519
Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- VDyne, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to collect safety and efficacy data of the VDyne System to support Conformitè Europëenne (CE) Mark of the VDyne System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VDyne Transcatheter Tricuspid Valve Replacement System | The study investigational device is the VDyne Transcatheter Tricuspid Valve Replacement System. |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2026-12-30
- Completion
- 2030-12-30
- First posted
- 2023-04-04
- Last updated
- 2025-11-03
Locations
21 sites across 11 countries: Australia, Austria, Belgium, Czechia, Denmark, Germany, Netherlands, New Zealand, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05797519. Inclusion in this directory is not an endorsement.