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
- Conditions
- Atrioventricular BlockBradyarrhythmiaLeft Bundle Branch Area Pacing
- Interventions
- Procedure: Right ventricular pacingProcedure: Left bundle branch area pacing
- Registration Number
- NCT05585411
- Lead Sponsor
- Yonsei University
- Brief 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%).
- Detailed Description
PROTECT-SYNC study is a multicenter, randomized, controlled trial that is designed to assess whether LBBAP may reduce the risk of composite primary endpoint including all cause mortalty, HF hospitalization and/or urgent HF related visit, occurrence of pacing induced CMP, and CRT-upgrade event, compared to RVP in patients who require substantial (\>40%) ventricular pacing. Patients who require pacemaker and substantial (\>40%) ventricular pacing will be randomized to LBBAP or RVP group, and 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
3 Scheduled to receive a pacemaker implant 4. Substantial percentage of V pacing rate (>40%) is anticipated
Exclusion criteria:
- 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)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RVP group Right ventricular pacing In this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed. LBBAP group Left bundle branch area pacing In this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method all cause mortality during 2 years after pacemaker implantation All cause deaths including cardiovascular and non-cardiovascular deaths.
Cardiovascular mortality during 2 years after pacemaker implantation Cardiovascular death
LBBAP related complications during 2 years after pacemaker implantation Loss of lead function or need for lead revision, extraction, replacement for any reason
Rate of LV systolic dysfunction 6month and 2yr after pacemaker implantation LVEF \<50% and absolute reduction in LVEF \>10%, and/or an increase in LVESV ≥15%.
LBB capture failure during 2 years after pacemaker implantation failed LBB capture, confirmed by investigator
Short-term procedure and Device related complications during 1wk after pacemaker implantation composite of device and procedure related complications until 7 days after procedure
success rate of LBBAP implantation during 3days after pacemaker implantation LBBAP success is defined if ventricular lead is successfully placed at interventricular septum and RBB configuration observed during unipolar tip pacing.
Long-term procedure and Device related complications during 1wk after pacemaker implantation composite of device and procedure related complications after 7 days after procedure
Changes in cardiopulmonary exercise test parameters 6month and 2yr after pacemaker implantation (VO2 peak, Exercise intensity, Peak Respiratory Exchange Ratio (Peak RER), Exercise time, age predicted aerobic capacity, VE/VCO2 slope, Lactate threshold, Max predicted HR, Max HR / Max predicted HR, presence of ST change , AF at Baseline, Incident AF during exercise
Heart failure hospitalization during 2 years after pacemaker implantation 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.
Incidental atrial fibrillation during 2 years after pacemaker implantation Newly developed atrial fibrillation in patients without documented atrial fibrillation
Trial Locations
- Locations (8)
GyeongSang National University Changwon Hospital
🇰🇷Changwon, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chungju, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Kyunghee University hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Saint Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Bucheon Sejong Hospital
🇰🇷Bucheon, Korea, Republic of