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PASCAL Precision-GDMT Registry (PASCAL)

11 maj 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Studietyp

Observationell

Inskrivning (Beräknad)

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Christophe LE ROUX, MSc
Telefonnummer: +33(0)760278098
E-post: cleroux@cerc-europe.org

Studera Kontakt Backup

Namn: Basile Gravez, PhD
Telefonnummer: +33(0)789452048
E-post: bgravez@cerc-europe.org

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen
Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Change in GDMT score at 12 months, compared to baseline Tidsram: 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

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Heart failure hospitalisation rate at 12 months Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ceric Sàrl

Utredare

Huvudutredare: Thibault Lhermusier, MD, PhD, CHU Rangueil

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

31 augusti 2027

Studieregistreringsdatum

Först inskickad

5 maj 2026

Först inskickad som uppfyllde QC-kriterierna