Trials / Unknown
UnknownNCT03225612
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Mitralign, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation. The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.
Detailed description
A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.
Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation
- Tricuspid Valve Insufficiency
- Heart Valve Disease
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) | Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus. |
Timeline
- Start date
- 2017-05-22
- Primary completion
- 2018-06-01
- Completion
- 2022-11-01
- First posted
- 2017-07-21
- Last updated
- 2018-02-07
Locations
11 sites across 4 countries: Germany, Italy, Netherlands, Portugal
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03225612. Inclusion in this directory is not an endorsement.