Mitral Valve Screening Survey (MVSS)

August 25, 2025 updated by: Medstar Health Research Institute

Mitral Valve Screening Survey (MVSS)

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).

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Cardiovascular Research Group
        • Principal Investigator:
          • Timothy Byrne, DO
        • Contact:
    • California
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Florida
      • Clearwater, Florida, United States, 33756
      • Fort Myers, Florida, United States, 33908
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Kansas City, Kansas, United States, 66103
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Emmanuel Daon, MD
        • Contact:
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Ignacio Inglessis, MD
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Recruiting
        • Ascension St. John's Hospital
        • Contact:
        • Principal Investigator:
          • Theodore Schreiber, MD
    • New York
    • Ohio
      • Columbus, Ohio, United States, 43210
    • Oregon
      • Portland, Oregon, United States, 98239
        • Recruiting
        • Oregon Health Sciences University
        • Principal Investigator:
          • Harsh Golwala, MD
        • Contact:
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This multicenter prospective study will enroll consecutive subjects, who after referral for TMVI, are deemed not to be candidates for TMVI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Subjects fail screening for TMVI
Subjects with symptomatic mitral valve disease who after referral for TMVI, are deemed not to be candidates for TMVI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • MVSS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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