Mitral Valve Screening Survey (MVSS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Disease
- Sponsor
- Medstar Health Research Institute
- Enrollment
- 1000
- Locations
- 16
- Primary Endpoint
- All-cause mortality
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
All-cause mortality
Time Frame: 1 year
Secondary Outcomes
- Reason for screen failure(Baseline)
- All-cause mortality(30 days, 1 year, and annually up to 5 years)
- Hospitalizations(30 days, 1 year, and annually up to 5 years)
- Mitral intervention(30 days, 1 year, and annually up to 5 years)