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PASCAL Precision-GDMT Registry

Study acronym: PASCAL
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv2
  2. Study First Submitted
Ceric Sàrl
10 trials monitored
See 1 trial at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
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.
Trial Details
NCT Number NCT07578129
Lead Sponsor Ceric Sàrl
Conditions
(from sponsor)		 Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction, Left Ventricular Dysfunction, Left Ventricular Ejection Fraction
Related terms Tricuspid Valve Insufficiency, Ventricular Dysfunction, Left
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov