Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

Overview

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

Full Title of Study: “Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2025

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.

Interventions

  • Procedure: setting up of the pace maker
    • Setting up of a pace maker using a 3-dimensional (3D) guidance technique

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Setting up with success of the Left Ventricular lead
    • Time Frame: during the time of the setting up of the pace maker
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • GCS Ramsay Santé pour l’Enseignement et la Recherche
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Nicolas DETIS, MD, 3 59 75 75 75, nicolasledet@hotmail.com

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