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

RecruitingNAAges 18 Years - anyAllInstitut d'Investigació Biomèdica de Bellvitge
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Pacemaker implant
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Where

6 sites
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital General Universitario de Castellón
Castellon, Spain
Hospital Virgen de las Nieves
Granada, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain
Hospital La Fe
Valencia, Spain
Hospital Lozano Blesa
Zaragoza, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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