No registrations found.
ID
Source
Brief title
Health condition
Bradycardia, Heart Failure, Left bundle branch block
Sponsors and support
Intervention
Outcome measures
Primary outcome
To demonstrate superiority of left ventricular septal pacing (LVSP) over RV pacing and to investigate the additional effect of capturing the left bundle branch in LVSP. This will be done by studying differences in electrophysiological and hemodynamic effects of different LV septal pacing lead penetration depths.
Secondary outcome
• Study the global and regional strain patterns measured by echocardiography during LVSP.
• Compare effects of LVSP between patients with structurally normal hearts and patients with reduced LV ejection fraction.
• To study ventricular remodelling assessed through echocardiography after three months in all patients.
Background summary
Recent studies have described left ventricular septal pacing deep in the interventricular septum (IVS) as a new conduction system pacing strategy. However, information on the electrophysiological and hemodynamic effects of the pacing depth within the IVS and the additional effect of capturing the left bundle branch (LBB) is unknown.
The primary objective is to demonstrate superiority of left ventricular (LV) septal pacing (LVSP) over right ventricular (RV) pacing and to investigate the additional effect of capturing the left bundle branch in LVSP. This will be done by studying differences in electrophysiological and hemodynamic effects at different LV lead penetration depths. Secondary objective is to study differences in electrical and hemodynamic effects between patients with structurally normal hearts and patients with reduced left LV function.
Study objective
1) Left bundle branch area pacing is superior over right ventricular (RV) pacing. 2) Acute electrical and hem-dynamic effect is comparable between LV septal pacing and left bundle branch pacing.
Study design
1day FU, 6 months FU
Intervention
Left bundle branch area pacing
Inclusion criteria
Indication for permanent cardiac pacing:
o pacing indication in structurally normal heart because of:
• sinus node dysfunction (SND)
• atrioventricular block (AVB)
• atrial tachy-arrhythmia refractory to anti-arrhythmic medications that required atrioventricular node ablation
o Pacing indication with reduced LV ejection fraction
• pacing indication with reduced LV ejection fraction and expected high percentage of ventricular pacing
• heart failure with wide QRS and LBBB and reduced LVEF
Exclusion criteria
• Age < 18 years
• Incapable of giving informed consent
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9748 |
| Other | METC azM/UM : METC 20-066 |