TriClip CED RWE Study
- Conditions
- Tricuspid Regurgitation
- Registration Number
- NCT06920745
- Lead Sponsor
- Abbott Medical Devices
- Brief 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.
- Detailed Description
The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2200
- 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)
- Patients with less than severe Tricuspid Regurgitation
- Patients with a prior history of surgical or transcatheter tricuspid valve replacement
- Patients with a surgical or transcatheter aortic or mitral valve intervention prior to index
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite of heart failure hospitalization or all-cause mortality 2 years Compare the rate of composite endpoint at 2 years between the treatment and control groups.
- Secondary Outcome Measures
Name Time Method Tricuspid valve re-intervention 2 years Report the rate at 2 years for the treatment group
Related Research Topics
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Trial Locations
- Locations (1)
Abbott
🇺🇸Santa Clara, California, United States