Trials / Unknown
UnknownNCT02574650
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (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 early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR). 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 and whom left-sided valve surgery is not planned. The study will include up to 30 subjects from up to 6 sites. Follow-up evaluations will be conducted through 2-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) delivered by a percutaneous transcatheter procedure. |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2018-05-01
- Completion
- 2019-05-01
- First posted
- 2015-10-14
- Last updated
- 2017-10-27
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02574650. Inclusion in this directory is not an endorsement.