Mitral Valve Screening Survey (MVSS)

MedStar Health

Status: Enrolling

Conditions: Mitral Valve Disease

Study type: Observational

Funder types: Other

Identifiers

NCT04736667

MVSS

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Subjects fail screening for TMVI

Description:

Subjects with symptomatic mitral valve disease who after referral for TMVI, are deemed not to be candidates for TMVI.