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NCT04736667 Clinical Trial

Mitral Valve Screening Survey

Mitral Valve Disease Clinical Trial

— MVSS  

Official title:
Mitral Valve Screening Survey (MVSS)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04736667
Other study ID # MVSS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 6, 2021
Est. completion date February 2027

Study information
Verified date June 2024
Source Medstar Health Research Institute
Contact Kassandra Lopez
Phone 202-877-2452
Email kassandra.lopez@medstar.net
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date February 2027
Est. primary completion date February 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Unity Health Toronto; St. Michael's Hospital Toronto Ontario
Canada St. Paul's Hospital Vancouver British Columbia
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Chicago Illinois
United States Morton Plant Hospital Clearwater Florida
United States The Ohio State University Columbus Ohio
United States Ascension St. John's Hospital Detroit Michigan
United States HealthPark Medical Center Fort Myers Florida
United States University of Kansas Medical Center Kansas City Kansas
United States Keck Hospital of USC Los Angeles California
United States Aurora St. Luke's Medical Center Milwaukee Wisconsin
United States NYU Langone Health - Long Island Mineola New York
United States Phoenix Cardiovascular Research Group Phoenix Arizona
United States Oregon Health Sciences University Portland Oregon
United States MedStar Washington Hospital Center Washington District of Columbia
United States MercyOne Iowa Heart Center West Des Moines Iowa

Sponsors (1)
Lead Sponsor Collaborator
Medstar Health Research Institute

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality 1 year
Secondary Reason for screen failure Baseline
Secondary All-cause mortality 30 days, 1 year, and annually up to 5 years
Secondary Hospitalizations 30 days, 1 year, and annually up to 5 years
Secondary Mitral intervention 30 days, 1 year, and annually up to 5 years
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