Mitral Valve Disease
Conditions
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.
Interventions
None listed
Sponsors
Medstar Health Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Contacts
Primary ContactKassandra Lopez
Backup ContactJake Sutton
Outcome results
None listed