Tricuspid Valve Clinical Trials

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Forma

Principal Investigator: Susheel K. Kodali, MD

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Tricuspid Regurgitation (TR) is a disorder in which the Tricuspid valve, the valve in between the two right chambers that does not close properly. As a result, blood flows backward through the Tricuspid valve. The purpose of the study is to evaluate the safety and effectiveness of the Edwards Tricuspid Transcatheter Repair System in treating TR. The tricuspid valve repair implant consists of a foam encased in a balloon that is intended to fill the space in the diseased tricuspid heart valve and provide a surface for native valve leaflets to minimize the incorrect flow of blood in your heart. Up to 30 patients will be enrolled in the study at 5 centers within the United States.. All enrolled participants will be assessed for clinical follow-up at  1 month, 6 months, 1 year and annually for 3 years post implant procedure.

Sponsored by Edwards Lifesciences

ClinicalTrials.gov

For further information, please contact Kate Dalton, RN at keb2114@cumc.columbia.edu

Scout

Principal Investigator: Rebecca T. Hahn, MD

 Early feasibility of the mitralign percutaneous tricuspid valve annuloplasty system (ptvas) for symptomatic chronic functional tricuspid regurgitation.

This is 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 device uses a catheter-based approach to suture the tricuspid valve thus decreasing the size of valve and therefore decrease leaking.  30 subjects with chronic functional tricuspid regurgitation from up to six sites in the U.S. will be treated with the PTVAS
All subjects receiving an implant will be followed for 2 years. Follow-up will comprise of a subject visit to the out-patient clinic and a transthoracic echocardiography to assess tricuspid function and the cardiac hemodynamic status at all follow-up visits. Also, laboratory, quality of life questionnaires and a 6-minute walking distance test will be performed. At the 6-month follow-up visit, the trans-esophageal echocardiography and a right heart catheterization will be repeated. Subjects will be administered aspirin for a minimum of 6 months after the procedure.
Patients will follow up at 1, 3, 6, 12 and 24 months.

Sponsored by Mitralign, Inc.

ClinicalTrials.gov

For further information, please contact Kate Dalton, RN at keb2114@cumc.columbia.edu