Comparing two pacing methods to prevent heart dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of left septal pacing (LVSP) and left bundle branch pacing (LBBP) against conventional right ventricular apical pacing (RVAP) in patients with high-degree atrioventricular block. The study will involve a multi-center, prospective, randomized design, where participants will be assigned to one of the pacing methods during pacemaker implantation. The primary goal is to determine whether LVSP can better preserve left ventricular function compared to LBBP and RVAP in patients with preserved or mildly deteriorated left ventricular ejection fraction. Outcomes will be assessed over a 12-month period following the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age of 18 years or more.
2. Preserved or mild deteriorated LVEF (Simpson \>40%) assessed by a recent (\<1 month before implantation) transthoracic echocardiography.
3. Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (\>80%).
4. Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.

Exclusion Criteria:

1. Patients with indication for implantable cardioverter defibrillator device.
2. Patients with indication for a CRT device, with LVEF \<40%.
3. Patients with previous severe LVD (Simpson LVEF \<30%) and a recovered LVEF.
4. History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization.
5. Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment.

Where it's running

• Hospital del Mar - IMIM
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Ermengol Valles, PhD
• Email: ermengolvalles@mac.com
• Phone: 0034666437038

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.