Tricuspid Replacement with the Evoque valve system: Imaging and Characterization by Computed Tomography
The TRIC-CT study is an investigator initiated, national, multi-centre, prospective, interventional, single-armed clinical trial. The objective is to evaluate the prognostic value of pre- and post- procedural multimodality assessment in identifying predictors of favorable clinical response at 12 months following Transcatheter Tricuspid Valve Replacement (TTVR).
The study plans to enroll 60 patients with ≥severe Tricuspid Regurgitation; patients will be followed up to 1-year.
TTVR will be performed using EVOQUE Tricuspid Valve Replacement System, by Edwards Lifesciences.
Sponsor
sponsored by
& supported by  |
Primary endpoints
Favorable clinical response at 12 months defined as:
- Being alive
- Free from Heart Failure Hospitalization
- Free from tricuspid valve reintervention
- Clinical improvement defined by at least one of:
- Kansas City Cardiomyopathy Questionnaire overall summary (KCCQ-OS) ≥15 points compared to baseline
- 6 (six)-minute walk test (6MWT) ≥30 meters compared to baseline.
CERC Services
- Full Services
Countries
France
Number of investigational sites
14
Number of patients
60 patients to be enrolled
