Improvement in Guideline-Directed Medical Therapy after Tricuspid Transcatheter Edge-to-Edge Repair in Participants with Reduced Left Ventricular Function
Study Design: Prospective, national / multi-center, open-label, single arm, exploratory registry
ID: NCT07578129 | PASCAL Precision-GDMT Registry | ClinicalTrials.gov
Sponsor
sponsored by
& supported by
Study objectives
The objective of this study is to evaluate whether successful T-TEER, performed as part of routine clinical practice in participants with at least severe TR and left ventricular dysfunction can be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT).
Hypothesis: Successful T-TEER in participants with at least severe TR and left ventricular dysfunction can be associated with an improvement in up-titration of GDMT.
Primary endpoints
Change in GDMT score at 12 months, compared to baseline
CERC Services
- Study documents draft and review
- Regulatory submissions
- Sites Contracts & Fees management
- Project management
- EDC and data management
- Central data monitoring
- Safety reporting
- Statistical Activities
- Final study report
Countries
France
Number of investigational sites
10 sites
Number of patients
50 patients
