Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

Study Overview
=================
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.

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

Conditions
-----------------
Cardiac Anomaly

Intervention / Treatment
-----------------
* Procedure: setting up of the pace maker


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3-dimensional guidance technique<br>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<br>* Setting up of a pace maker using a 3-dimensional (3D) guidance technique<br>|

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 |