Actively Recruiting
Led by Medstar Health Research Institute · Updated on 2025-08-29
1000
Participants Needed
16
Research Sites
N/A
Total Duration
This research aims to better understand patients with mitral valve disease who do not qualify for transcatheter mitral valve intervention (TMVI). It focuses on examining their clinical and anatomical characteristics, as well as tracking their health outcomes over time. The study collects detailed information to learn more about the natural history of those who fail screening for these investigational heart valve procedures. The study is an observational registry involving patients referred for TMVI but found ineligible for these treatments after screening. There are no assigned treatments or interventions since the study observes patients who are not candidates for TMVI. Data collected includes baseline health information, imaging characteristics, and reasons for screening failure. Participants will be followed to record outcomes such as mortality, hospitalizations, and any mitral valve interventions at intervals including 30 days, 1 year, and annually for up to 5 years. Researchers will monitor all-cause mortality at 1 year as the primary outcome and collect data on hospitalizations and interventions as secondary outcomes. The study began in August 2021 and is expected to continue through February 2027.
CONDITIONS
Mitral Valve Screening Survey
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants with symptomatic mitral valve disease who fail screening for transcatheter mitral valve interventions are observed to collect clinical outcomes and relevant data.
Visits at 30 days, 1 year, and annually up to 5 years
Total: 16 locations
1
Phoenix Cardiovascular Research Group
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Keck Hospital of USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
4
Morton Plant Hospital
Clearwater, Florida, United States, 33756
Actively Recruiting
5
HealthPark Medical Center
Fort Myers, Florida, United States, 33908
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
MercyOne Iowa Heart Center
West Des Moines, Iowa, United States, 50266
Actively Recruiting
8
University of Kansas Medical Center
Kansas City, Kansas, United States, 66103
Actively Recruiting
9
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Ascension St. John's Hospital
Detroit, Michigan, United States, 48236
Actively Recruiting
11
NYU Langone Health - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
12
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
13
Oregon Health Sciences University
Portland, Oregon, United States, 98239
Actively Recruiting
14
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
15
St. Paul's Hospital
Vancouver, British Columbia, Canada
Actively Recruiting
16
Unity Health Toronto; St. Michael's Hospital
Toronto, Ontario, Canada
Actively Recruiting
K
Kassandra Lopez
J
Jake Sutton
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Giorgio A Medranda, Toby Rogers, Thomas Modine...
https://pubmed.ncbi.nlm.nih.gov/36266153Ron Waksman, Giorgio A Medranda
https://pubmed.ncbi.nlm.nih.gov/34600872