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The TRICURE EFS Study

RECRUITINGN/ASponsored by TRiCares
Actively Recruiting
PhaseN/A
SponsorTRiCares
Started2024-09-11
Est. completion2026-03
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT06506942

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions4

Cardiovascular DiseasesHeart DiseaseHeart Valve DiseasesTricuspid Valve Regurgitation

Locations8 sites

Piedmont Healthcare Inc.
Atlanta, Georgia, 30309
Pradeep Yadav, MD4046056517Pradeep.Yadav@piedmont.org
Northwestern
Chicago, Illinois, 60611
Anita Asgar, MD312-664-3278anita.asgar@northwestern.edu
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
Gorav Ailawadi, MD
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Paul Sorajja, MD612-863-3833info@mhif.org
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, 10032
Susheel Kodali, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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