Left Ventricular Cardiac Dysfunction, Left Ventricular Dysfunction, Left Ventricular Ejection Fraction, Left Ventricular (LV) Systolic Dysfunction, Tricuspid Insufficiency, Tricuspid Regurgitation (TR)
Conditions
Keywords
T-TEER, Severe Tricuspid regurgitation, left ventricular dysfunction, GDMT score, NHYA, KCCQ
Brief summary
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.
Interventions
None listed
Sponsors
Ceric Sàrl
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 curatorship or if they are deprived of their liberty by judicial or administrative decision * Participation in another trial, which would lead to deviations in the preparation or performance of the intervention or the post-implantation management from this protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in GDMT score at 12 months, compared to baseline | From enrollment up to 12 months post-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline | At enrollment and at 12 months | Comparison of the KCCQ score at 12 months with the KCCQ score at baseline |
| New York Heart Association (NYHA) class at 12 months compared to baseline | At enrollment and at baseline | Comparison of the NYHA class at 12 months with the NYHA class at baseline |
| Heart failure hospitalisation rate at 12 months | From enrollment up to 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 | From enrollment up to 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 | At enrollment and at 12 months | Comparison of the 12-months level of NT-pro BNP to the baseline level of NT-pro BNP |
Contacts
CONTACTChristophe LE ROUX, MSc
CONTACTBasile Gravez, PhD
PRINCIPAL_INVESTIGATORThibault Lhermusier, MD, PhD
CHU Rangueil
Outcome results
None listed