Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™. (SCOUT)
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.
|Chronic Symptomatic Functional Tricuspid Regurgitation Tricuspid Valve Insufficiency Heart Valve Disease||Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for Symptomatic Chronic Functional Tricuspid Regurgitation|
- Technical success at 30-days [ Time Frame: 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.
- Secondary safety and performance endpoints mid-term and long-term [ Time Frame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months ]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.
- 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 [ Time Frame: 24-months with endpoints measured at dishcarge, 1, 3, 6, 12 and 24 months ]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.
|Study Start Date:||November 2015|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Open Label
Non-randomized, open label clinical study that intends to treat up to 30 subjects with the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) using standard of care techniques and services that are typically used for structural heart procedures.
Device: Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02574650
|Contact: Gisella Blanchetteemail@example.com|
|Contact: Sara Vidmarfirstname.lastname@example.org|
|United States, California|
|Cedars-Sinai Medical Center||Recruiting|
|Los Angeles, California, United States, 90048|
|Contact: Saibal Kar, MD 310-423-3977 email@example.com|
|Principal Investigator: Saibal Kar, MD|
|United States, District of Columbia|
|MedStar Washington Hospital Center||Recruiting|
|Washington, D.C., District of Columbia, United States, 20010|
|Contact: Lowell Satler, MD 202-877-5975 firstname.lastname@example.org|
|Principal Investigator: Lowell Satler, MD|
|United States, Florida|
|Delray Medical Center||Recruiting|
|Delray Beach, Florida, United States, 33484|
|Contact: Laura Hudson 561-495-3145 Laura.Hudson@tenethealth.com|
|Principal Investigator: Brijeshwar Maini, MD|
|United States, Georgia|
|Atlanta, Georgia, United States, 30309|
|Contact: Christopher Meduri, MD 404-605-6517 email@example.com|
|Principal Investigator: Christopher Meduri, MD|
|United States, Illinois|
|Northwestern University / Bluhm Cardiovascular Institute||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Stuart Rich, MD 312-695-9979 firstname.lastname@example.org|
|Principal Investigator: Stuart Rich, MD|
|United States, New York|
|Columbia University Medical Center / New York-Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10032|
|Contact: Rebecca Hahn, MD 212-305-7060 email@example.com|
|Principal Investigator: Rebecca Hahn, MD|
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22908|
|Contact: Scott Lim, MD 434-982-1058 firstname.lastname@example.org|
|Principal Investigator: Scott Lim, MD|
|Principal Investigator:||Rebecca Hahn, MD||Columbia Unviersity Medical Center / New York-Presbyterian Hospital|
|Principal Investigator:||Christopher Meduri, MD, MPH||Piedmont Healthcare|