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
Yonsei University
450 participants
Nov 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- At least 19 years old and willing and capable to give informed consent
- Patients who is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
- Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (\>40%) is anticipated
Exclusion Criteria9
- Incapacitated or unable to read or write
- Patient who is an indication of ICD or CRT
- History of prosthetic valve surgery on tricuspid valve
- Prior myocardial infarction including ventricular septum
- Life expectancy \< 12 months due to any condition
- Unavailable for at least 24 months of follow-up visits
- Pregnant or breastfeeding at the time of signing consent
- Prior Heart transplant surgery
- Persistent Left Superior Vena Cava (PLSVC)
Interventions
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 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)
View Full Details on ClinicalTrials.gov
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NCT05585411