RecruitingNot ApplicableNCT05585411

PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial

Sponsor

Yonsei University

Enrollment

450 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Bradyarrhythmia Atrioventricular Block Left Bundle Branch Area Pacing

Summary

PROTECT-SYNC study is a multicenter, randomized, controlled trial. A total of 7 medical centers across Republic of Korea will enroll 450 patients during 2 years of enrollment period, and followed for 2 years of follow-up period. The purpose of this study to compare the clinical outcomes of Left Bundle Branch Area Pacing (LBBAP) compared to Right Ventricular Pacing (RVP) in bradyarrhythmia patients who require high burden of ventricular pacing (\>40%).

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study (PROTECT-SYNC) is comparing two methods of pacemaker implantation in people who need a pacemaker and are expected to rely on it for pacing their heart frequently. It compares left bundle branch area pacing (a newer, more natural-feeling approach) versus traditional right ventricular pacing, to see which better prevents heart failure and abnormal heart function long term. **You may be eligible if...** - You are 19 or older - You are scheduled to receive a pacemaker - Your heart is expected to be paced more than 40% of the time - You are willing to return for follow-up visits for at least 24 months **You may NOT be eligible if...** - You already have or need a defibrillator (ICD) or cardiac resynchronization therapy (CRT) device - You have had a prosthetic tricuspid valve replacement - You previously had a heart attack involving the ventricular septum - You have had a heart transplant - You are pregnant or breastfeeding - Your life expectancy is less than 12 months 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.

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Interventions

PROCEDURELeft bundle branch area pacing

LBBAP success is defined if ventricular lead is successfully placed at interventricular septum and RBB configuration observed during unipolar tip pacing. LBB capture is defined if fulfilling criterion 1 and at least one in criteria 2. 1. RBBB configuration observed during unipolar tip pacing 2. One of the following should be met: 1. Abrupt shortening of Stim-LVAT (stimulus to peak of the R wave in V6 \[LV activation time\]) of \>10ms during increasing output 2. Short and constant stim-LVAT and the shortest stim-LVAT \<75ms in non-LBBB and \<85ms in LBBB 3. Programmed stimulation by pacing lead changes QRS morphology from nonselective LBB to LV septal capture 4. LBB potential (LBB-V interval of 15 to 35ms) 5. Transition from nonselective LBB capture to selective LBB capture at near threshold outputs If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be deep septal pacing (DSP).

PROCEDURERight ventricular pacing

Right ventricular pacing is the traditional pacing modality for ventricular pacing. Implantation of a RV pacing lead (apex or septum of right ventricle) will be attempted using the standard-of-care technique first