Back to resultsCardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation (CRT3D)
Primary Purpose
Cardiac Anomaly
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
setting up of the pace maker
Sponsored by
About this trial
This is an interventional treatment trial for Cardiac Anomaly
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.
Sites / Locations
- Hôpital Privé Le BoisRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
3-dimensional guidance technique
Arm Description
3-dimensional (3D) guidance technique to position the heart probes in the setting up of a pace maker
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05429645
First Posted
June 17, 2022
Last Updated
October 25, 2022
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05429645
Brief Title
Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation
Acronym
CRT3D
Official Title
Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation: CRT3D Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Anomaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3-dimensional guidance technique
Arm Type
Experimental
Arm Description
3-dimensional (3D) guidance technique to position the heart probes in the setting up of a pace maker
Intervention Type
Procedure
Intervention Name(s)
setting up of the pace maker
Intervention Description
Setting up of a pace maker using a 3-dimensional (3D) guidance technique
Primary Outcome Measure Information:
Title
Setting up with success of the Left Ventricular lead
Description
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
Time Frame
during the time of the setting up of the pace maker
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas DETIS, MD
Phone
3 59 75 75 75
Ext
+33
Email
nicolasledet@hotmail.com
Facility Information:
Facility Name
Hôpital Privé Le Bois
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas DETIS, MD
Phone
3 59 75 75 75
Ext
+33
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cardiac Resynchronization Under Electroanatomical Guidance After Failure of Primary Implantation
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