Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study (LBBAP)
Primary Purpose
Bradyarrhythmia, Pacemaker Syndrome, Biventricular Cardiac Pacemaker Malfunction
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Left Bundel Area Pacing
Sponsored by
About this trial
This is an interventional diagnostic trial for Bradyarrhythmia focused on measuring Left bundle area pacing, Pacemaker, Wide QRS
Eligibility Criteria
Inclusion Criteria:
- 30 patients with a functional LBB-AP pacemaker
Exclusion Criteria:
- Age < 18 years
- Previous cardiac surgery
- Cardiomyopathy with documented ventricular scar
- Patients with prior pacemaker
Sites / Locations
- UZ BrusselRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Body surface mapping
Arm Description
With the Insite Vest, activation of the epicardium will be performed.
Outcomes
Primary Outcome Measures
Epicardial map
Activation patterns (visual inspection) on non-invasive 3D ECG mapping
Epicardial map
Activation time (ms) on non-invasive 3D ECG mapping
Secondary Outcome Measures
Echo parameters for resynchronization
LVEF (%)
Echo parameters for resynchronization
intraventricular delay (ms)
Full Information
NCT ID
NCT05401851
First Posted
April 4, 2022
Last Updated
May 27, 2022
Sponsor
Universitair Ziekenhuis Brussel
1. Study Identification
Unique Protocol Identification Number
NCT05401851
Brief Title
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
Acronym
LBBAP
Official Title
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 21, 2022 (Anticipated)
Study Completion Date
March 21, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Study of the ventricular activation patterns during left bundle area pacing and compare it with baseline activation during normal sinus rhythm in patients with and without baseline bundle branch conduction disorder.
Detailed Description
Right ventricular (RV) pacing has long been the gold standard treatment for symptomatic brady arrhythmias. Right ventricular apical pacing has shown to cause electrical and mechanical desynchrony resulting in left ventricular (LV) dysfunction, and, in some cases, clinical heart failure together with other mechanical and arrhythmic complications. Hence, it was necessary to find a more physiologic method of pacing that ensures synchrony. His bundle pacing was first described in 2000, and is more recently adapted as a pacing method with less deleterious effects on the RV. However, lead dislodgement, high pacing thresholds, battery depletion, and difficulty identifying the exact location of His bundle were the most significant concerns related to this method. Subsequently, left bundle branch area pacing (LBB-AP), first described in 2017 by Huang et al, has emerged as safe alternative with excellent lead stability and capture threshold, and more ability to correct distal conduction disease as compared to His bundle pacing. Recent studies report promising mid-term outcome concerning left ventricular desynchrony. To the best of our knowledge, bi-ventricular activation was never studied in patients with LBB-AP.
Multiple tools have been used to assess biventricular (BiV) synchrony specially with chronic resynchronization therapy (CRT) including echocardiography and 12 lead ECG. Eschalier et al. found that epicardial noninvasive ECG mapping, was better at predicting clinical CRT response than QRS duration or the presence of LBBB. Activation patterns and timings with RV apical pacing, native LBBB, and BiV pacing have been well studied using this tool. With LBBP, however, these activation parameters have not yet been described.
This study aims to evaluate bi-ventricular activation in patients equipped with LBB-AP using non-invasive 3D mapping system in patients with or without baseline ventricular conduction disorder.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradyarrhythmia, Pacemaker Syndrome, Biventricular Cardiac Pacemaker Malfunction
Keywords
Left bundle area pacing, Pacemaker, Wide QRS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Body surface mapping
Arm Type
Other
Arm Description
With the Insite Vest, activation of the epicardium will be performed.
Intervention Type
Device
Intervention Name(s)
Left Bundel Area Pacing
Intervention Description
RV Lead will be placed deep in the interventricular septum
Primary Outcome Measure Information:
Title
Epicardial map
Description
Activation patterns (visual inspection) on non-invasive 3D ECG mapping
Time Frame
1 day
Title
Epicardial map
Description
Activation time (ms) on non-invasive 3D ECG mapping
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Echo parameters for resynchronization
Description
LVEF (%)
Time Frame
90 days
Title
Echo parameters for resynchronization
Description
intraventricular delay (ms)
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
30 patients with a functional LBB-AP pacemaker
Exclusion Criteria:
Age < 18 years
Previous cardiac surgery
Cardiomyopathy with documented ventricular scar
Patients with prior pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo de Asmundis, MD, PhD
Phone
+32024763704
Email
HRMC@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie Dubois
Phone
+3224763254
Email
aurelie.dubois@uzbrussel.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo De Asmundis, MD, PhD
Organizational Affiliation
UZ Brussels
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo de Asmundis, MD, PhD
Email
HRMC@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Aurélie Dubois
Phone
+3224763254
Email
aurelie.dubois@uzbrussel.be
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Bi-ventricular Epicardial Activation in Left Bundle Area Pacing: a Comparison Study
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