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PASCAL Precision-GDMT Registry (PASCAL)

11 mei 2026 bijgewerkt door: Ceric Sàrl

Improvement in Guideline-Directed Medical Therapy After Tricuspid Transcatheter Edge-to-Edge Repair in Participants With Reduced Left Ventricular Function

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Christophe LE ROUX, MSc
Telefoonnummer: +33(0)760278098
E-mail: cleroux@cerc-europe.org

Studie Contact Back-up

Naam: Basile Gravez, PhD
Telefoonnummer: +33(0)789452048
E-mail: bgravez@cerc-europe.org

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Participants from France with at least severe tricuspid regurgitation with associated left ventricular dysfunction

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Participants with at least severe tricuspid regurgitation and associated left ventricular dysfuntion Participants of the cohort undergoing a successful T-TEER will be enrolled in the study.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Change in GDMT score at 12 months, compared to baseline Tijdsspanne: 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.	From enrollment up to 12 months post-procedure

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Heart failure hospitalisation rate at 12 months Tijdsspanne: From enrollment up to 12 months	Number of hospitalizations related to heart failure at 12 months divided by the number of patients	From enrollment up to 12 months
All-cause hospitalisation rate at 12 months Tijdsspanne: From enrollment up to 12 months	Number of hospitalisations for all cause at 12 months divided by the number of patients	From enrollment up to 12 months
NT-pro BNP at 12 months compared to baseline Tijdsspanne: At enrollment and at 12 months	Comparison of the 12-months level of NT-pro BNP to the baseline level of NT-pro BNP	At enrollment and at 12 months
New York Heart Association (NYHA) class at 12 months compared to baseline Tijdsspanne: At enrollment and at baseline	Comparison of the NYHA class at 12 months with the NYHA class at baseline	At enrollment and at baseline
Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months compared to baseline Tijdsspanne: At enrollment and at 12 months	Comparison of the KCCQ score at 12 months with the KCCQ score at baseline	At enrollment and at 12 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ceric Sàrl

Onderzoekers

Hoofdonderzoeker: Thibault Lhermusier, MD, PhD, CHU Rangueil

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

31 augustus 2027

Studieregistratiedata

Eerst ingediend

5 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria