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.
ID
Bron
Verkorte titel
Aandoening
Bradycardia, Heart Failure, Left bundle branch block
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
1day FU, 6 months FU
Onderzoeksproduct en/of interventie
Left bundle branch area pacing
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Age < 18 years
• Incapable of giving informed consent
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9748 |
| Ander register | METC azM/UM : METC 20-066 |