Mitral Valve Screening Survey
Purpose
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).
Condition
- Mitral Valve Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Subjects fail screening for TMVI | Subjects with symptomatic mitral valve disease who after referral for TMVI, are deemed not to be candidates for TMVI. |
Recruiting Locations
Kansas City, Kansas 66103
More Details
- Status
- Recruiting
- Sponsor
- Medstar Health Research Institute
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.