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RECRUITINGINTERVENTIONAL

Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction

Left Septal Pacing or Left Bundle Branch Pacing to Avoid Left Ventricle Systolic Dysfunction. A Multicenter Randomized Trial From the STAY Investigators

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form, and complying with follow-up. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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).

Locations (1)

Hospital del Mar - IMIM
Barcelona, Spain