Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

NCT ID: NCT05429645

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2024-01-23

Brief Summary

The purpose of the study is to assess the feasibility of cardiac resynchronization under electroanatomic guidance in the event of primary implantation failure due to catheterization failure or instability in the coronary sinus ostium

Detailed Description

As part of this study, to avoid surgery, the doctor will use a 3-dimensional (3D) guidance technique to position the heart probes in an optimal position during a new endovascular intervention.

Conditions

Cardiac Anomaly

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

3-dimensional guidance technique

3-dimensional (3D) guidance technique to position the heart probes in the setting up of a pace maker

Group Type: EXPERIMENTAL

setting up of the pace maker

Intervention Type: PROCEDURE

Setting up of a pace maker using a 3-dimensional (3D) guidance technique

Interventions

setting up of the pace maker

Setting up of a pace maker using a 3-dimensional (3D) guidance technique

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patient with indication for implantation of a classic multisite pacemaker;
• New York Heart Association II/IV patient despite optimal medical treatment;
• Patient with left ventricular ejection fraction ≤35%;
• Patient with a widened QRS > 120ms;
• Patient with at least one lateral coronary sinus vein visualized on angiography during the 1st procedure (if performed);
• Patient with failure of resynchronization via the endovenous route due to difficulty in accessing the coronary sinus or instability in the coronary sinus;
• Patient having been informed and having signed an informed consent form;
• Patient able to understand the information related to the study (absence of linguistic, psychological, cognitive problem, etc.), and to complete questionnaires.

Exclusion Criteria

• Patient with resynchronization failure due to occlusion of the superior vena cava;
• Patient with no usable lateral coronary sinus vein;
• Patient with a life expectancy < 3 months;
• Patient wearing a vena cava filter;
• Patient with active sepsis;
• Pregnant or likely to be pregnant (of childbearing age, without effective contraception) or breastfeeding;
• Patient participating in another clinical trial, or in a period of exclusion from another clinical trial;
• Patient not benefiting from a social security scheme.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Euraxi Pharma

INDUSTRY

Sponsor Role: collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Privé Le Bois

Lille, , France

Countries

France

Other Identifiers

2022-A00811-42

Identifier Type: -

Identifier Source: org_study_id