Tricuspid Regurgitation
Conditions
Keywords
TriClip, Coverage with Evidence Development, Tricuspid Transcatheter Edge-to-Edge Repair
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.
Interventions
DEVICEThe TriClip System
The TriClip System
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tricuspid valve re-intervention | 2 years | Report the rate at 2 years for the treatment group |
Countries
United States
Contacts
Primary ContactTRICARE
Outcome results
None listed