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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23434
Enrollment
40
Registered
2021-09-21
Start date
2021-05-19
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bradycardia, Heart Failure, Left bundle branch block

Interventions

Left bundle branch area pacing

Sponsors

Medtronic
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Age < 18 years • Incapable of giving informed consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
• 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.

Contacts

Public ContactLuuk Heckman

Maastricht University

l.heckman@maastrichtuniversity.nl0683183324

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)