RECRUITING

The TRICURE EFS Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-09-11
Study Completion:2030-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06506942

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients
  2. * Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
  3. * Institutional Heart Team evaluates patient as being at increased operative risk
  1. * Patient in need of emergent intervention
  2. * Patient who is hemodynamically unstable
  3. * Anatomical contraindications for implantation with study device
  4. * Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Contacts and Locations

Study Contact

Esther Gerteis
CONTACT
+41796015318
gerteis@tricares.de

Principal Investigator

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 Locations (Sites)

Piedmont Healthcare Inc.
Atlanta, Georgia, 30309
United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
New York, New York, 10032
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11
Study Completion Date2030-10

Study Record Updates

Study Start Date2024-09-11
Study Completion Date2030-10

Terms related to this study

Additional Relevant MeSH Terms

  • Tricuspid Valve Regurgitation
  • Heart Valve Diseases
  • Cardiovascular Diseases