Mitral Valve Screening Survey
- Conditions
- Mitral Valve Disease
- Registration Number
- NCT04736667
- Lead Sponsor
- Medstar Health Research Institute
- 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).
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Subject failed screening for TMVI
- Under 18 years of age
- Subject unable or unwilling to give informed consent
- Subject proceeded with TMVI.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause mortality 1 year
- Secondary Outcome Measures
Name Time Method All-cause mortality 30 days, 1 year, and annually up to 5 years Reason for screen failure Baseline Mitral intervention 30 days, 1 year, and annually up to 5 years Hospitalizations 30 days, 1 year, and annually up to 5 years
Trial Locations
- Locations (16)
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
HealthPark Medical Center
🇺🇸Fort Myers, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
NYU Langone Health - Long Island
🇺🇸Mineola, New York, United States
Ascension St. John's Hospital
🇺🇸Detroit, Michigan, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Unity Health Toronto; St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
MercyOne Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
Phoenix Cardiovascular Research Group
🇺🇸Phoenix, Arizona, United States
MedStar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States