Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation

Cardiac Anomaly Clinical Trial

— CRT3D  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05429645
• Other study ID #: 2022-A00811-42
• Status: Terminated
• Phase: N/A
• Start date: July 28, 2022
• Est. completion date: June 9, 2023

Study information

• Verified date: March 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 9, 2023
• Est. primary completion date: June 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Anomaly
• Heart Defects, Congenital

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Privé Le Bois	Lille

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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