Pacemaker and defibrillator: Pacemaker implantation, which can be a regular right ventricle apical lead or a LBBAP lead (LBBP or LVSP dependint on the criteria accomplished).
Study summary
Right ventricular apical pacing (RVAP) can produce left ventricular dysfunction (LVD). Conduction system pacing (CSP) has been used successfully to reverse LVD in patients with left bundle branch block. A recent randomized controlled trial (RCT) has demonstrated that CSP, mostly performed with left bundle branch area pacing (LBBAP), can preserve normal ventricular function and heart failure admissions compared to RVAP in the setting of a high burden of ventricular pacing11 (Stay Trial).
Criteria to assess the LBBAP distinguishes those cases in which the LBB is captured (LBBP) from those in which only the muscular septum surrounding the LBB is captured (LVSP). To date, data regarding LVSP to preserve left ventricle ejection fraction (LVEF) is scarce and limited to non-randomized studies.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
LVEF evolution — At 12 months after the pacemaker implantation Change in the value (%) of LVEF at 12 months compared to basal
Admission due to HF — From date of implantation until the date of first admission due to HF, whichever came first, assessed up to 12 months Hospital admission due to episode of heart failure (new onset HF or worsening from baseline NYHA)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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