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.
Participants of age ≥ 18 years
≥ severe tricuspid regurgitation
LVEF < 50%
Written informed consent of the patient or her/his legal representative
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)
Participants from France with at least severe tricuspid regurgitation with associated left ventricular dysfunction
Case-only
Prospective
Not listed
Change in GDMT score at 12 months, compared to baseline
The GDMT score is calculated by adding all scores of each HF therapy. The minimum score corresponds to no medication taken and is 0. The maximum score is 11 and corresponds to all medications taken at the maximum dose. An intermediate score would be all medications taken at the intermediate dose and would be 6 (ACEi/ARB/ARNI = 2, BB = 2, MRA at 50-99% = 2). A low score would be ACEi/ARB/ARNI, BB and MRA at low dose and would be 3. The dose of diuretics, although not included in the GDMT score, should be collected and considered separately.
Heart failure hospitalisation rate at 12 months
Number of hospitalizations related to heart failure at 12 months divided by the number of patients
All-cause hospitalisation rate at 12 months
Number of hospitalisations for all cause at 12 months divided by the number of patients
NT-pro BNP at 12 months compared to baseline
Comparison of the 12-months level of NT-pro BNP to the baseline level of NT-pro BNP
New York Heart Association (NYHA) class at 12 months compared to baseline
Comparison of the NYHA class at 12 months with the NYHA class at baseline
This trial is not recruiting at the moment. You can still explore other options:
