Trials / Recruiting
RecruitingNCT04905017
Trisol System EFS Study
Early Feasibility Study of the Trisol System
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Trisol Medical · 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 Trisol system safety and performance to treat patients with moderate or greater tricuspid regurgitation (TR).
Detailed description
A prospective, single-arm, open-label, multi-center early feasibility clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Transcatheter Tricuspid Valve Replacement | Replacement of the tricusupid valve using Trisol System in a transcatheter approach |
Timeline
- Start date
- 2022-03-02
- Primary completion
- 2026-01-01
- Completion
- 2031-07-01
- First posted
- 2021-05-27
- Last updated
- 2025-11-21
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04905017. Inclusion in this directory is not an endorsement.