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

Completed

Conditions: bradycardia
10007521
heart failure

Registration Number: NL-OMON49575

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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 tachyarrhythmia refractory to antiarrhythmic medications that required
atrioventricular node ablation
o Pacing indication with reduced LV ejection fraction (LVEF)
• pacing indication with reduced LVEF and expected high percentage of
ventricular pacing
• Heart failure with wide QRS and left bundle branch block (LBBB) and reduced
LVEF

Exclusion Criteria

• >2 premature ventricular complexes on standard 12-lead ECG on all ECG*s
within 3 months prior to implantation.
• Age < 18 years
• Incapable of giving informed consent

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study parameters/endpoints:<br /><br>• To show superiority in electrophysiological effect (standard deviation of<br /><br>activation times (SDAT) measured by the ECG-Belt) of LV septum pacing over RV<br /><br>septum pacing in patients indicated for permanent cardiac pacing.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints:<br /><br>• Comparing vectorcardiographic characteristics (QRS area) during pacing at<br /><br>different depths within the IVS;<br /><br>• Comparing electrocardiographic characteristics (QRS duration, QRS morphology)<br /><br>during pacing at different depths within the interventricular septum (IVS);<br /><br>• Comparing systolic and diastolic blood pressure (invasively measured) during<br /><br>pacing at different depths within the IVS;<br /><br>• Determine the ability to capture the left bundle in LVS pacing;<br /><br>• Assess global and regional LV strain patterns measured by echocardiography<br /><br>during LVS pacing;<br /><br>• Assess reverse remodelling after three months in patients undergoing deep LV<br /><br>septal pacing with a CRT indication.</p><br>