Comparing two heart pacing methods to protect left ventricle pumping function
Tests two heart pacing methods in adults with AV block to protect heart pumping.
Plain-language title generated from the registry record
Registry title: Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction
Key facts
- Where
- Barcelona, SpainSee the site
Where in Spain
- Hospital del Mar - IMIMBarcelona, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Parc de Salut Mar
- Trial code
- NCT06707662
- Record updated
- 11 February 2025
- Original description
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).Read full original descriptionShow less
Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators
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.
Inclusion: Age of 18 years or more; Preserved or mild deteriorated LVEF (Simpson >40%) assessed by a recent (<1 month before implantation) transthoracic echocardiography; Indication for pacing based on the presence of a high degree AVB, and consequently with an anticipated high burden of ventricular pacing (>80%); Life expectancy of more than 12 months and capability to understand the protocol, signing informed consent form, and complying with follow-up.
Exclusion: History of myocardial infarction/revascularization or cardiac surgery within 6 months before randomization; Pregnancy, active cancer treatment, or participation in another clinical trial with active treatment; Patients with indication for a CRT device, with LVEF <40%; Patients with previous severe LVD (Simpson LVEF <30%) and a recovered LVEF; Patients with indication for implantable cardioverter defibrillator device.