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The TRICURE EFS Study

TRiCares · NCT06506942

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
15
US sites recruiting
8
Study start
September 11, 2024
Record last updated
July 23, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Being studied: Transcatheter Tricuspid Valve Replacement

Conditions: Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Adult patients
  • Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
  • Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion Criteria

  • Patient in need of emergent intervention
  • Patient who is hemodynamically unstable
  • Anatomical contraindications for implantation with study device
  • Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Recruiting US locations

  • Piedmont Healthcare Inc.

    Atlanta, GA 30309

    Site contact: Pradeep Yadav, MD · 404-605-6517 · pradeep.yadav@piedmont.org

  • Northwestern

    Chicago, IL 60611

    Site contact: Anita Asgar, MD · 312-664-3278 · anita.asgar@northwestern.edu

  • University of Michigan Hospital and Health Systems

    Ann Arbor, MI 48109

    Site contact: Gorav Ailawadi, MD · 734-936-4974 · ailawadi@umich.edu

  • Minneapolis Heart Institute Foundation

    Minneapolis, MN 55407

    Site contact: Vinayak Bapat, MD · 612-863-6900 · vinayak.bapat@allina.com

  • Columbia University Medical Center/ NewYork Presbyterian Hospital

    New York, NY 10032

    Site contact: Susheel Kodali, MD · 212-342-0444 · sk2427@cumc.columbia.edu

  • Montefiore

    The Bronx, NY 10461

    Site contact: Azeem Latib, MD · 718-920-4212 · mlatib@montefiore.org

  • The Christ Hospital

    Cincinnati, OH 45219

    Site contact: Santiago Garcia, MD · 513-206-1222 · santiago.garcia@thechristhospital.com

  • Medical University of South Carolina

    Charleston, SC 29425

    Site contact: Nicholas S. Amoroso, MD · 8438760940 · amoroson@musc.edu

Study contacts (from the official record)

  • Esther Gerteis · +41796015318 · gerteis@tricares.de
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The TRICURE EFS Study (NCT06506942) | Bored Studies