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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants of age ≥ 18 years
* ≥ severe tricuspid regurgitation
* LVEF \< 50%
* Written informed consent of the patient or her/his legal representative
* Patient understands the purpose, the potential risks as well as benefits of the trial and is willing to participate in all parts of the follow-up
* Planned follow-up within a dedicated heart failure clinic as part of routine care.
Exclusion Criteria:
* 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)
* prior tricuspid valve intervention
* severe leaflet degeneration or tricuspid valve anatomy precluding successful device placement
* primary tricuspid valve disease
* COPD requiring home oxygen therapy
* active endocarditis, or recent episode within 4 weeks of discontinuation of antibiotic therapy
* participants with unstable hemodynamic condition
* significant co-morbidities resulting in an expected less than 12-month life expectancy
* The presence of other anatomic or comorbid conditions or other medical, social or psychological conditions that in the investigators' opinion could limit the subject's ability to participate in the clinical study and its follow-up.
* Participants under judicial protection, guardianship or curato…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in GDMT score at 12 months, compared to baseline
Timeframe: From enrollment up to 12 months post-procedure