PASCAL Precision-GDMT Registry

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCeric Sàrl

About this trial

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.

Eligibility criteria

Qualifiers

Participants of age ≥ 18 years

≥ severe tricuspid regurgitation

LVEF < 50%

Written informed consent of the patient or her/his legal representative

Disqualifiers

Anatomy unsuitable for TEER as determined by local heart team

severe mitral regurgitation (defined as an EROA>40 mm2) treated (surgically or percutaneously) less than 3 months prior

severe left ventricular dysfunction (defined as an LVEF <20%)

systolic pulmonary artery pressure >70 mmHg (right heart catheterization)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

50 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators