Mechanistic insight in left ventricular septal and left bundle branch pacing.

Recruiting

• Conditions: Bradycardia, Heart Failure, Left bundle branch block

• Registration Number: NL-OMON23434
• Lead Sponsor: Medtronic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
• Study the global and regional strain patterns measured by echocardiography during LVSP.<br>• Compare effects of LVSP between patients with structurally normal hearts and patients with reduced LV ejection fraction.<br>• To study ventricular remodelling assessed through echocardiography after three months in all patients.