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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
Cedars-Sinai Medical Center
Los Angeles, California, United States
RECRUITINGKaiser Permanente
San Francisco, California, United States
RECRUITINGMedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
RECRUITINGDelray Medical Center
Delray Beach, Florida, United States
RECRUITINGPiedmont Healthcare
Atlanta, Georgia, United States
RECRUITINGNorthwestern University / Bluhm Cardiovascular Institute
Chicago, Illinois, United States
RECRUITINGMinneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
RECRUITINGColumbia University Medical Center / New York-Presbyterian Hospital
New York, New York, United States
RECRUITINGHouston Methodist
Houston, Texas, United States
RECRUITINGUniversity of Virginia
Charlottesville, Virginia, United States
RECRUITING...and 1 more locations
Technical success at 30-days
Technical success is defined as freedom from death with: successful access, delivery and retrieval of the device delivery system, and deployment and correct positioning of the intended device(s), and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure.
Time frame: 30-days
Secondary safety and performance endpoints mid-term and long-term
The secondary objectives of the study are to evaluate the acute, mid-term and long-term safety of the device and effects of the device on performance, functional and quality of life parameters, as well as technical, procedural and individual patient successes.
Time frame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
Number of participants with a change in Minnesota Living with Heart Failure (MLWHF) Questionnaire and 6-minute walk test (6MWT) as compared to pre-treatment questionnaire responses and pre-treatment total distance walked
Participants will complete a MLWHF questionnaire and 6MWT before treatment and at each post treatment follow-up check. Percent change over baseline will be calculated.
Time frame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months
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