NCT04736667

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).

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
9mo left

Started Aug 2021

Longer than P75 for all trials

Geographic Reach
2 countries

16 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Aug 2021Feb 2027

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 6, 2021

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

5.5 years

First QC Date

January 29, 2021

Last Update Submit

August 25, 2025

Conditions

Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    1 year

Secondary Outcomes (4)

  • 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

Study Arms (1)

Subjects fail screening for TMVI

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Subject failed screening for TMVI

You may not qualify if:

  • Under 18 years of age
  • Subject unable or unwilling to give informed consent
  • Subject proceeded with TMVI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Phoenix Cardiovascular Research Group

Phoenix, Arizona, 85016, United States

RECRUITING

Keck Hospital of USC

Los Angeles, California, 90033, United States

RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Morton Plant Hospital

Clearwater, Florida, 33756, United States

RECRUITING

HealthPark Medical Center

Fort Myers, Florida, 33908, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MercyOne Iowa Heart Center

West Des Moines, Iowa, 50266, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66103, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Ascension St. John's Hospital

Detroit, Michigan, 48236, United States

RECRUITING

NYU Langone Health - Long Island

Mineola, New York, 11501, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health Sciences University

Portland, Oregon, 98239, United States

RECRUITING

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

RECRUITING

Unity Health Toronto; St. Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

Related Publications (2)

  • Medranda GA, Rogers T, Modine T, Latib A, Jorde U, Bapat V, Sorajja P, Rowland M, Sutton JA, Baig S, Asch FM, Garcia-Garcia HM, Ben-Dor I, Satler LF, Waksman R. The Clinical Profile and Natural History of Patients Who Fail Screening for Transcatheter Mitral Valve Replacement: Rationale and Design of the Prospective Multicenter Mitral Valve Screening Survey (MVSS). Cardiovasc Revasc Med. 2023 Feb;47:72-75. doi: 10.1016/j.carrev.2022.09.003. Epub 2022 Sep 11.

    PMID: 36266153DERIVED

  • Waksman R, Medranda GA. Transcatheter Mitral Valve Replacement: Size Matters. JACC Cardiovasc Interv. 2021 Oct 25;14(20):2228-2230. doi: 10.1016/j.jcin.2021.08.040. Epub 2021 Sep 29. No abstract available.

    PMID: 34600872DERIVED

Central Study Contacts

Kassandra Lopez

CONTACT

202-877-2452kassandra.lopez@medstar.net

Jake Sutton

CONTACT

202-877-6624joseph.a.sutton@medstar.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

August 6, 2021

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

US(14)CA(2)