Mitral Valve Screening Survey

Recruiting

• 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.

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study First Posted: 2021-02-03
• Study Start: 2021-08-06
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	1 year

Secondary Outcome Measures

Name	Time	Method
Hospitalizations	30 days, 1 year, and annually up to 5 years
Mitral intervention	30 days, 1 year, and annually up to 5 years
All-cause mortality	30 days, 1 year, and annually up to 5 years
Reason for screen failure	Baseline

Trial Locations

Locations (16)

Phoenix Cardiovascular Research Group; 🇺🇸 Phoenix, Arizona, United States

Keck Hospital of USC; 🇺🇸 Los Angeles, California, United States

MedStar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Morton Plant Hospital; 🇺🇸 Clearwater, Florida, United States

HealthPark Medical Center; 🇺🇸 Fort Myers, Florida, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

MercyOne Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Ascension St. John's Hospital; 🇺🇸 Detroit, Michigan, United States

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