Status:
RECRUITING
TriClip CED RWE Study
Lead Sponsor:
Abbott Medical Devices
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18+ years
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 Transcathet...
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...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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 within 90 days prior to index
Key Trial Info
Start Date :
July 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
2200 Patients enrolled
Trial Details
Trial ID
NCT06920745
Start Date
July 8 2025
End Date
July 1 2032
Last Update
August 11 2025
Active Locations (1)
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1
Abbott
Santa Clara, California, United States, 95054