Trials / Recruiting
RecruitingNCT04433065
TTVR Early Feasibility Study
The Early Feasibility Study of the Transcatheter Tricuspid Valve Replacement System Transfemoral System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Medtronic Cardiovascular · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this early feasibility study is to gain early clinical insight into the performance of the Intrepid transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.
Detailed description
Multi-center, prospective, non-randomized, investigational, and pre-market.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intrepid™ TTVR System | Device: Intrepid™ TTVR System |
Timeline
- Start date
- 2020-10-20
- Primary completion
- 2026-07-30
- Completion
- 2031-07-30
- First posted
- 2020-06-16
- Last updated
- 2026-03-09
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04433065. Inclusion in this directory is not an endorsement.