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

Condition(s) studied

Investigational drug(s) / intervention(s)

Left 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).

Right 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

Study 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

Primary outcome measure(s)

• composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy — during 2 years after pacemaker implantation
  All-cause death: including cardiovascular and non-cardiovascular deaths. Heart failure hospitalization: An unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required intravenous therapy. Occurrence of Pacing induced cardiomyopathy : LVEF \<50% and absolute LVEF decline ≥10% or increase in LVESV ≥15% Upgrade to cardiac resynchronization therapy (CRT): Upgrade from pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less).

Trial sites (8)

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