Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study

Status unconfirmed · Not applicable

Conditions studied: Mitral Valve Regurgitation

In brief

The purpose of this study is to assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

Key facts

Study ID

NCT02768402

Run by

Caisson Interventional LLC

People needed

20

Starts

2016-06-01

Expected to finish

2023-12-01

Last updated by the study team

2020-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has severe mitral regurgitation
• New York Heart Association (NYHA) Class II, III, IVa or heart failure
• High risk for cardiovascular surgery

You may not qualify if…

• Excessive calcification or thickening of mitral valve annulus, severe mitral stenosis, fused commissures, valvular vegetation or mass
• Left ventricular end diastolic dimension > 7cm
• Left ventricular outflow tract obstruction
• Severe right ventricular dysfunction
• Stroke within 90 days; transischemic attack or myocardial infarction within 30 days of the index procedure

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• New York University Langone Medical Center — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• OhioHealth — Columbus, Ohio, United States
• Saint Thomas Heart — Nashville, Tennessee, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Swedish Health Services — Seattle, Washington, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.