Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation (CRT3D)

Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study

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

Study Overview

• Status: Terminated
• Conditions: Cardiac Anomaly
• Intervention / Treatment: Procedure: setting up of the pace maker

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Privé Le Bois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3-dimensional guidance technique; 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; Setting up of a pace maker using a 3-dimensional (3D) guidance technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Collaborators: Euraxi Pharma

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Actual): January 23, 2024
• Study Completion (Actual): January 23, 2024

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 17, 2022
• First Posted (Actual): June 23, 2022

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: 2022-A00811-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No