TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients ≥ 18 years of age at time of implant
• Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)
Locations
United States
California
Abbott
RECRUITING
Santa Clara
Contact Information
Primary
TRICARE
TRICARE@abbott.com
(408) 845-3000
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2032-07
Participants
Target number of participants: 2200
Treatments
Treatment Group
Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system
Control Group
Patients with symptomatic, severe or greater TR without T-TEER
Related Therapeutic Areas
Sponsors
Leads: Abbott Medical Devices