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NOT YET RECRUITING
NCT07578129

PASCAL Precision-GDMT Registry

Sponsor: Ceric Sàrl

View on ClinicalTrials.gov

Summary

The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be associated with an improvement in up-titration of guideline-directed medical therapy (GDMT). The main question it aims to answer is: Does the tricuspid insufficiency repair with the Pascal Precision System increases the dose of the medications used for heart failure therapy in the study population 12 months after tricuspid repair, as compared to the dose taken at baseline. Participants undergoing tricuspid repair and fulfilling all inclusion/exclusion criteria will be asked to answer heart failure assessment as well as quality of life questionnaires at baseline and at 12 months post intervention. Medication monitoring will be performed throughout the study.

Official title: Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2026-08-01

Completion Date

2027-08-31

Last Updated

2026-05-13

Healthy Volunteers

No