PASCAL Precision-GDMT Registry (PASCAL)

May 11, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in GDMT score at 12 months, compared to baseline
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure hospitalisation rate at 12 months
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ceric Sàrl

Investigators

  • Principal Investigator: Thibault Lhermusier, MD, PhD, CHU Rangueil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

May 5, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDW-07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan has been established in the protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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