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NCT04736667Recruiting

Mitral Valve Screening Survey

Medstar Health Research Institute

Start Date

8/6/2021

Completion Date

2/1/2027

Summary

This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).

Detailed Description

Numerous transcatheter mitral valve interventions have emerged as a treatment option for patients with mitral valve disease. Development of transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) continues to progress with ongoing rigorous clinical trials of several experimental devices. However, despite being referred for TMVI, most patients do not pass stringent screening criteria for these investigational devices and are not offered TMVI. In this prospective multicenter registry, baseline demographics, anatomical/imaging characteristics, and clinical outcomes of patients who fail screening for TMVI will be prospectively collected into a registry database.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject failed screening for TMVI Exclusion Criteria: * Under 18 years of age * Subject unable or unwilling to give informed consent * Subject proceeded with TMVI.

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Conditions

Mitral Valve Disease

Locations

Phoenix Cardiovascular Research Group

Phoenix, Arizona 85016

United States

Keck Hospital of USC

Los Angeles, California 90033

United States

MedStar Washington Hospital Center

Washington D.C., District of Columbia 20010

United States

Morton Plant Hospital

Clearwater, Florida 33756

United States

HealthPark Medical Center

Fort Myers, Florida 33908

United States

Northwestern University

Chicago, Illinois 60611

United States

MercyOne Iowa Heart Center

West Des Moines, Iowa 50266

United States

University of Kansas Medical Center

Kansas City, Kansas 66103

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Ascension St. John's Hospital

Detroit, Michigan 48236

United States

NYU Langone Health - Long Island

Mineola, New York 11501

United States

The Ohio State University

Columbus, Ohio 43210

United States

Oregon Health Sciences University

Portland, Oregon 98239

United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin 53215

United States

St. Paul's Hospital

Vancouver, British Columbia

Canada

Unity Health Toronto; St. Michael's Hospital

Toronto, Ontario

Canada