RecruitingNot ApplicableNCT06707662

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

Sponsor

Parc de Salut Mar

Enrollment

150 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

AV Block

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two pacemaker techniques — left septal pacing and left bundle branch pacing — to see which one better preserves heart pump function over time in patients who need a pacemaker for a serious heart rhythm problem (high-degree heart block). **You may be eligible if...** - You are 18 or older - You have a normal or mildly reduced heart pump function (ejection fraction above 40%) confirmed by recent echocardiogram - You have a high-degree heart block requiring a pacemaker, and doctors expect you to be paced more than 80% of the time - Your life expectancy is more than 12 months and you can consent and attend follow-up **You may NOT be eligible if...** - You need a defibrillator (ICD) or cardiac resynchronization device (CRT) - Your heart pump function is severely reduced (ejection fraction below 30%) now or in the past - You have had a recent heart attack, heart surgery, or coronary bypass Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPacemaker 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06707662

Related Trials

BIOTRONIK Investigation of the LivIQ Leadless Pacemaker System

NCT071183582 locations

Randomized Study of Physiological vs Right Ventricular Pacing in Patients With Normal Ventricular Function Post TAVI

NCT061975031 location