Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

NCT05429645 | Terminated

• 1 other identifier: 2022-A00811-42
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Cardiac Anomaly

Outcome Measures

Primary Outcomes (1)

• Setting up with success of the Left Ventricular lead

  Feasibility of cardiac resynchronization under 3 dimension assistance in the event of primary implantation failure will be assessed by the proportion of patients for whom the Left Ventricular lead has been placed successfully with a pacemaker

  during the time of the setting up of the pace maker

Study Arms (1)

3-dimensional guidance technique

EXPERIMENTAL

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

Procedure: setting up of the pace maker

Interventions

setting up of the pace maker PROCEDURE

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

3-dimensional guidance technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Hôpital Privé Le Bois

Lille, France

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 23, 2022
• Study Start: July 28, 2022
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2024
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)