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

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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

Exclusion Criteria:

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
At extreme risk of having cardiovascular surgery

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Charanjit Rihal, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Charanjit Rihal, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials