Comparing different pacing methods to prevent heart damage in patients needing a pacemaker
Official title: Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
Run by Institut d'Investigació Biomèdica de Bellvitge · NCT06474819 · Data updated 2026-11-12
This study is testing whether using a pacemaker in a specific way can help prevent heart damage in people getting their first pacemaker due to a heart block.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 326 (estimated) |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge Academic / other |
| Locations | 6 sites (Barcelona and 5 other locations) |
| Status | Recruiting |
| Started | July 12, 2024 |
| Main results expected | January 12, 2027 |
| Study ends | January 12, 2027 |
| Registry record updated | July 15, 2024 |
| Trial ID | NCT06474819 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with complete heart block or second-degree AV block requiring their first pacemaker and having a left ventricular ejection fraction greater than 50%.
✕Probably not a fit
Patients with a life expectancy of less than 12 months or those with severe cardiac conditions requiring immediate intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized controlled trial aims to evaluate the effectiveness of left septal versus right ventricular apical pacing in patients requiring their first pacemaker due to high-degree atrioventricular block. Participants will be randomized in a 1:1 ratio to receive either pacing method, with the primary goal of assessing the incidence of pacing-induced cardiomyopathy within the first year. The study focuses on patients with a left ventricular ejection fraction greater than 50%, ensuring a specific population is targeted for this intervention.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of pacing-induced cardiomyopathy in patients with high pacing needs.
How similar studies have gone: While this approach is being tested in this trial, similar pacing strategies have shown promise in previous studies, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Spain Recruiting -
Hospital Vall d'Hebrón
Barcelona, Spain Not yet recruiting -
Hospital General Universitario de Castellón
Castellon, Spain Not yet recruiting -
Hospital Virgen de las Nieves
Granada, Spain Not yet recruiting -
Hospital La Fe
Valencia, Spain Not yet recruiting -
Hospital Lozano Blesa
Zaragoza, Spain Not yet recruiting
Study contacts
- Principal investigator: Andrea Di Marco, MD, PhD — IDIBELL and Hospital Universitario de Bellvitge
- Study coordinator: Andrea Di Marco, MD, PhD
- Email: adimarco@bellvitgehospital.cat
- Phone: +34932 60 75 00
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.