RECRUITING

TriClip CED RWE 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

This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.

Official Title

TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)

Quick Facts

Study Start:2025-07-08
Study Completion:2032-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06920745

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. * Patients ≥ 18 years of age at time of implant
  2. * Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)
  1. * Patients with less than severe Tricuspid Regurgitation
  2. * Patients with a prior history of surgical or transcatheter tricuspid valve replacement
  3. * Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index

Contacts and Locations

Study Contact

TRICARE
CONTACT
(408) 845-3000
TRICARE@abbott.com

Study Locations (Sites)

Abbott
Santa Clara, California, 95054
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

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 Date2025-07-08
Study Completion Date2032-07

Study Record Updates

Study Start Date2025-07-08
Study Completion Date2032-07

Terms related to this study

Keywords Provided by Researchers

  • TriClip
  • Coverage with Evidence Development
  • Tricuspid Transcatheter Edge-to-Edge Repair

Additional Relevant MeSH Terms

  • Tricuspid Regurgitation