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

NARecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

November 1, 2022

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2026

Conditions
BradyarrhythmiaAtrioventricular BlockLeft Bundle Branch Area Pacing
Interventions
PROCEDURE

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)."

PROCEDURE

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

Trial Locations (8)

Unknown

RECRUITING

Bucheon Sejong Hospital, Bucheon-si

RECRUITING

GyeongSang National University Changwon Hospital, Changwon

RECRUITING

Chungbuk National University Hospital, Chungju

RECRUITING

Asan Medical Center, Seoul

RECRUITING

Kyunghee University hospital, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Seoul Saint Mary's Hospital, Seoul

NOT_YET_RECRUITING

Yonsei University Health System, Severance Hospital, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER