Mitral Valve Screening Survey

NCT ID: NCT04736667

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-06

Study Completion Date

2027-02-28

Brief Summary

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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

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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.

Conditions

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Mitral Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Subjects fail screening for TMVI

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Phoenix Cardiovascular Research Group

Phoenix, Arizona, United States

Site Status RECRUITING

Keck Hospital of USC

Los Angeles, California, United States

Site Status RECRUITING

MedStar Washington Hospital Center

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

Site Status RECRUITING

Morton Plant Hospital

Clearwater, Florida, United States

Site Status RECRUITING

HealthPark Medical Center

Fort Myers, Florida, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status RECRUITING

MercyOne Iowa Heart Center

West Des Moines, Iowa, United States

Site Status RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Ascension St. John's Hospital

Detroit, Michigan, United States

Site Status RECRUITING

NYU Langone Health - Long Island

Mineola, New York, United States

Site Status RECRUITING

The Ohio State University

Columbus, Ohio, United States

Site Status RECRUITING

Oregon Health Sciences University

Portland, Oregon, United States

Site Status RECRUITING

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status RECRUITING

Unity Health Toronto; St. Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Kassandra Lopez

Role: CONTACT

202-877-2452

Jake Sutton

Role: CONTACT

202-877-6624

Facility Contacts

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Jessica Byrne

Role: primary

Melody Nazar

Role: primary

Jose Escobar

Role: backup

Erin Collins

Role: primary

Jake Sutton

Role: backup

202-877-6624

John Menezes

Role: primary

Sue Fisher

Role: backup

Michelle Deckard

Role: primary

Allison Mossell

Role: primary

Nicole Kappel

Role: backup

Kendra Tuttle

Role: primary

Kartik Munshi

Role: primary

Tilitha Shawgo

Role: backup

Lina Fu

Role: primary

Renee Bess

Role: primary

Alison DePaolis

Role: primary

Melissa Batteria

Role: backup

Annie Kellum

Role: primary

Kalyn Ferguson

Role: backup

Anna Garwood

Role: primary

Taylor Toro

Role: backup

Dena Burke

Role: primary

Denise Bailey

Role: backup

Elizabeth Grieve

Role: primary

Anna Wilhelm

Role: backup

Ivana Kandic

Role: primary

Alana Harrington

Role: backup

References

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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.

Reference Type DERIVED
PMID: 36266153 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34600872 (View on PubMed)

Other Identifiers

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MVSS

Identifier Type: -

Identifier Source: org_study_id

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