An observational study in Tricuspid Insufficiency, Tricuspid Regurgitation (TR) and Left Ventricular Cardiac Dysfunction, sponsored by Ceric Sàrl. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Ceric Sàrl · Observational
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Ceric Sàrl is the lead sponsor of 17 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants from France with at least severe tricuspid regurgitation with associated left ventricular dysfunction
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants of the cohort undergoing a successful T-TEER will be enrolled in the study.
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.
Time frame: From enrollment up to 12 months post-procedure
Heart failure hospitalisation rate at 12 months
Number of hospitalizations related to heart failure at 12 months divided by the number of patients
Time frame: From enrollment up to 12 months
All-cause hospitalisation rate at 12 months
Number of hospitalisations for all cause at 12 months divided by the number of patients
Time frame: From enrollment up to 12 months
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
Time frame: At enrollment and at 12 months
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
Time frame: At enrollment and at baseline
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline
Comparison of the KCCQ score at 12 months with the KCCQ score at baseline
Time frame: At enrollment and at 12 months
No study locations are listed for this record.
Plan to share: No — No plan has been established in the protocol
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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