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

Recruiting now · Not applicable

Conditions studied: Complete Heart Block, Second Degree Atrioventricular Block Möbitz Type II

In brief

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.

Key facts

Study ID

NCT06474819

Run by

Institut d'Investigació Biomèdica de Bellvitge

People needed

326

Starts

2024-07-12

Expected to finish

2027-01-12

Last updated by the study team

2024-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hospital Universitario de Bellvitge — L'Hospitalet de Llobregat, Spain (enrolling)
• Hospital Vall d'Hebrón — Barcelona, Spain
• Hospital General Universitario de Castellón — Castellon, Spain
• Hospital Virgen de las Nieves — Granada, Spain
• Hospital La Fe — Valencia, Spain
• Hospital Lozano Blesa — Zaragoza, Spain

Full record on ClinicalTrials.gov

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