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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
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%).
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2022-11-01
Completion Date
2026-11-01
Last Updated
2026-01-05
Healthy Volunteers
No
Interventions
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
Locations (8)
Bucheon Sejong Hospital
Bucheon-si, South Korea
GyeongSang National University Changwon Hospital
Changwon, South Korea
Chungbuk National University Hospital
Chungju, South Korea
Asan Medical Center
Seoul, South Korea
Kyunghee University hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul Saint Mary's Hospital
Seoul, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea