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Clinical Trials/NCT06474819
NCT06474819
Recruiting
Not Applicable

Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy

Institut d'Investigació Biomèdica de Bellvitge6 sites in 1 country326 target enrollmentJuly 12, 2024
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ConditionsComplete Heart BlockSecond Degree Atrioventricular Block Möbitz Type II

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complete Heart Block
Sponsor
Institut d'Investigació Biomèdica de Bellvitge
Enrollment
326
Locations
6
Primary Endpoint
Pacing-induced cardiomyopathy
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 12, 2024
End Date
January 12, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andrea Di Marco

Principal Investigator

Institut d'Investigació Biomèdica de Bellvitge

Eligibility Criteria

Inclusion Criteria

  • •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 Criteria

  • •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.

Outcomes

Primary Outcomes

Pacing-induced cardiomyopathy

Time Frame: 12 months

Decrease in the left ventricular ejection fraction (LVEF) by \>10% as compared to the LVEF before pacemaker implant and final LVEF\<45%.

Secondary Outcomes

  • heart failure(12 months)
  • LVEF during follow-up(12 months)
  • Mitral and tricuspid regurgitation(12 months)
  • Brain Natriuretic Peptide levels(12 months)
  • New York Heart Association (NYHA) class(12 months)

Study Sites (6)

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