The TRICURE EFS Study

Description

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

Conditions

Tricuspid Valve Regurgitation, Heart Valve Diseases, Cardiovascular Diseases

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Study Overview

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Study Details

Study overview

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

The TRICURE EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility Study

The TRICURE EFS Study

Condition
Tricuspid Valve Regurgitation
Intervention / Treatment

-

Contacts and Locations

Atlanta

Piedmont Healthcare Inc., Atlanta, Georgia, United States, 30309

Ann Arbor

University of Michigan Hospital and Health Systems, Ann Arbor, Michigan, United States, 48109

New York

Columbia University Medical Center/ NewYork Presbyterian Hospital, New York, New York, United States, 10032

Charleston

Medical University of South Carolina, Charleston, South Carolina, United States, 29425

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

TRiCares,

Susheel Kodali, MD, PRINCIPAL_INVESTIGATOR, Columbia University Medical Center/ NewYork Presbyterian Hospital

Gorav Ailawadi, MD, PRINCIPAL_INVESTIGATOR, University of Michigan Hospital and Health Systems

Study Record Dates

2030-10