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PASCAL Precision-GDMT Registry (PASCAL)

11 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Christophe LE ROUX, MSc
Numéro de téléphone: +33(0)760278098
E-mail: cleroux@cerc-europe.org

Sauvegarde des contacts de l'étude

Nom: Basile Gravez, PhD
Numéro de téléphone: +33(0)789452048
E-mail: bgravez@cerc-europe.org

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
Change in GDMT score at 12 months, compared to baseline Délai: 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

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Heart failure hospitalisation rate at 12 months Délai: 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 Délai: 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 Délai: 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 Délai: 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 Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ceric Sàrl

Les enquêteurs

Chercheur principal: Thibault Lhermusier, MD, PhD, CHU Rangueil

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 août 2027

Achèvement de l'étude (Estimé)

31 août 2027

Dates d'inscription aux études

Première soumission

5 mai 2026

Première soumission répondant aux critères de contrôle qualité