Recruiting

Mitral Valve Screening

Sponsor:

Medstar Health Research Institute

Code:

NCT04736667

Conditions

Mitral Valve Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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).

Conditions

Mitral Valve Disease

Study ID

NCT04736667

Start date

Aug 6, 2021

Status verified date

Aug, 2025

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects fail screening for TMVI

Subjects with symptomatic mitral valve disease who after referral for TMVI, are deemed not to be candidates for TMVI.

Primary outcome measure

  • All-cause mortality [ Time Frame: 1 year ]

Central Contacts and Locations

Locations

Phoenix Cardiovascular Research Group

Recruiting

Phoenix, Arizona, United States, 85016

Contacts

Principal Investigator:

Timothy Byrne, DO

Keck Hospital of USC

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Vaughn Starnes, MD

MedStar Washington Hospital Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Principal Investigator:

Ron Waksman, MD

Morton Plant Hospital

Recruiting

Clearwater, Florida, United States, 33756

Contacts

Principal Investigator:

Joshua Rovin, MD

HealthPark Medical Center

Recruiting

Fort Myers, Florida, United States, 33908

Contacts

Principal Investigator:

Michael DeFrain, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Allison Mossell

allison.mossell@nm.org

Principal Investigator:

Christopher Malaisrie, MD

MercyOne Iowa Heart Center

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Principal Investigator:

Atul Chawla, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66103

Contacts

Kartik Munshi

kmunshi@kumc.edu

Tilitha Shawgo

tshawgo@kumc.edu

Principal Investigator:

Emmanuel Daon, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Ignacio Inglessis, MD

Ascension St. John's Hospital

Recruiting

Detroit, Michigan, United States, 48236

Contacts

Principal Investigator:

Theodore Schreiber, MD

NYU Langone Health - Long Island

Recruiting

Mineola, New York, United States, 11501

Contacts

Principal Investigator:

Richard Schwartz, DO

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Konstantinos Boudoulas, MD

Oregon Health Sciences University

Recruiting

Portland, Oregon, United States, 98239

Contacts

Anna Garwood

garwood@ohsu.edu

Taylor Toro

torot@ohsu.edu

Principal Investigator:

Harsh Golwala, MD

Aurora St. Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

Contacts

Principal Investigator:

Tanvir Bajwa, MD

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada

Contacts

Principal Investigator:

Robert Boone, MD

Unity Health Toronto; St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada

Contacts

Principal Investigator:

Neil Fam, MD

More Information

Sponsor

Medstar Health Research Institute

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medstar Health Research Institute on 2025-08-29.