Caisson Transcatheter Mitral Valve Replacement (TMVR)

Status unconfirmed · Not applicable

Conditions studied: Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Failure, Mitral Disease, Valve Heart Disease, Valve Disease, Heart

In brief

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

Key facts

Study ID

NCT03661398

Run by

Caisson Interventional LLC

People needed

75

Starts

2017-07-20

Expected to finish

2025-08-01

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; transient ischemic attack or myocardial infarction within 30 days of the index procedure

Where it is running

• Pennsylvania State University — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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