Status:
TERMINATED
Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation
Lead Sponsor:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Collaborating Sponsors:
Euraxi Pharma
Conditions:
Cardiac Anomaly
Eligibility:
All Genders
18+ years
Phase:
NA
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 instabi...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05429645
Start Date
July 28 2022
End Date
January 23 2024
Last Update
March 30 2025
Active Locations (1)
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1
Hôpital Privé Le Bois
Lille, France