Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Institut d'Investigació Biomèdica de Bellvitge
326 participants
Jul 12, 2024
INTERVENTIONAL
Conditions
Summary
Multicenter randomized controlled trial which will include patients with left ventricular ejection fraction \>50% requiring a first implant of a cardiac pacemaker with expected high pacing percentages. Patients will be randomized 1:1 to right ventricular apical pacing vs left septal or deep septal pacing. The primary endpoint will be pacing-induced cardiomyopathy during the first year of follow-up.
Eligibility
Inclusion Criteria3
- First implant of a single-chamber or dual chamber pacemaker due to persistent bradycardia associated with high degree atrio-ventricular (AV) block (complete AV block or second degree type II AV block), with second-degree type I AV block (symptomatic or associated with intra-hisian or infra-hisian block), or with atrial fibrillation with symptomatic slow ventricular rate (<45lpm).
- LVEF>50% at echocardiography performed maximum 7 days before pacemaker implant.
- Informed consent signature.
Exclusion Criteria4
- Life expectancy <12 months
- Severe cardiac valvular abnormality requiring intervention
- Unstable Angina, Acute myocardial infarction, coronary revascularization, valvular surgery or valvular percutaneous intervention in the 90 days prior to pacemaker implant.
- Inclusion in another trial which may influence the results of this study.
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Interventions
All patients in the study will have a clear indication for a permanent pacemaker. The type of device (single or dual chamber) will be chosen as per clinical practice. The only difference between the two groups of the study will be the position of the ventricular lead.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT06474819