Comparing different pacing methods to prevent heart damage in patients needing a pacemaker
Left Septal or Deep Septal Pacing to Prevent Pacing-induced Cardiomyopathy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 326 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Bellvitge Academic / other |
| Locations | 6 sites (Barcelona and 5 other locations) |
| Trial ID | NCT06474819 on ClinicalTrials.gov |
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.
Who should consider this trial
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%.
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.
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 performed: While this approach is being tested in this trial, similar pacing strategies have shown promise in previous studies, suggesting potential for success.
Eligibility criteria
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 this trial is running
Barcelona and 5 other locations
- 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 Universitario de Bellvitge — L'Hospitalet de Llobregat, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.