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PASCAL Precision-GDMT Registry

NCT07578129 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

  • Tricuspid Insufficiency
  • Tricuspid Regurgitation (TR)
  • Left Ventricular Cardiac Dysfunction
  • Left Ventricular (LV) Systolic Dysfunction
  • Left Ventricular Dysfunction
  • Left Ventricular Ejection Fraction

Sponsors & Collaborators

  • Ceric Sàrl

    lead INDUSTRY

Principal Investigators

  • Thibault Lhermusier, MD, PhD · CHU Rangueil

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-08-31
Completion
2027-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578129 on ClinicalTrials.gov