CHoice of OptImal transCatheter trEatment for Mitral Insufficiency Registry

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT04688190
Status
Recruiting
Apply to this trial

Conditions

  • Mitral Annular Calcification
  • Mitral Regurgitation
  • Mitral Valve Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

This multinational, investigator-initiated registry aims to investigate clinical outcomes of patients undergoing transcatheter mitral valve replacement (TMVR). The registry primarily focuses on patients treated with TMVR in real-world clinical practice. Patients evaluated for TMVR but not undergoing the procedure are no longer systematically included. Historical data may include such patients who subsequently underwent alternative treatments, including transcatheter edge-to-edge repair, mitral valve surgery, or medical/conservative therapy.

Key Dates

Start date
Nov 1, 2020
Status verified
May 2026
Primary completion
Dec 1, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Transcatheter Mitral Valve Replacement (TMVR)
    Patients with successful TMVR screening, who underwent Transcatheter Mitral Valve Replacement subsequently. All devices may be included.
  • Arm: Mitral transcatheter edge-to-edge repair (M-TEER)
    Patients with TMVR screening failure, who subsequently underwent interventional mitral valve edge-to-edge repair. Update: These patients are currently no longer systematically included.
  • Arm: Mitral valve surgery (Surgery)
    Patients with TMVR screening failure, who subsequently underwent mitral valve surgery (i.e., mitral valve repair or replacement). Update: These patients are currently no longer systematically included.
  • Arm: Medical/conservative therapy
    Patients with TMVR screening failure, who subsequently underwent conservative or optimal medical therapy. Update: These patients are currently no longer systematically included.

Primary Outcome Measure

Mitral insufficiency grade 2+ or more [ Time Frame: 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Tucson Medical CenterTucsonArizona85712
Thomas E. Waggoner
[email protected]
+1 520-327-5461
Cedars-Sinai Medical Center, Los AngelesLos AngelesCalifornia90048
Raj Makkar, MD
Sung-Han Yoon, MD
Tampa General HospitalTampaFlorida33606
Hiram G. Bezerra, MD
[email protected]
+1 813-844-7000
Brigham and Women's HospitalBostonMassachusetts02115
Tsuyoshi Kaneko, MD
Pinak Shah, MD
Minneapolis Heart Institute at Abbott Northwestern HospitalMinneapolisMinnesota55407
Paul Sorajja, MD
[email protected]
+1 612-863-4000
Morristown Medical CenterMorristownNew Jersey07960
Philippe Généreux, MD
[email protected]
+1 973-971-5000
Montefiore Medical CenterNew YorkNew York10461
Azeem Latib, MD
[email protected]
+1 718-920-4321
Andrea Scotti, MD
+1 718-920-4321
Oklahoma Heart HospitalOklahoma CityOklahoma73120
Naeem Tahirkheli, MD
[email protected]
+1 405-608-3200
Houston Methodist HospitalHoustonTexas77030
Michael Reardon, MD

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By research site
Tucson Medical Center· Tucson, AZCedars-Sinai Medical Center, Los Angeles· Los Angeles, CATampa General Hospital· Tampa, FLBrigham and Women's Hospital· Boston, MAMinneapolis Heart Institute at Abbott Northwestern Hospital· Minneapolis, MNMorristown Medical Center· Morristown, NJ

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