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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 8
- 主要终点
- composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy
研究概览
简要总结
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%).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Substantial percentage of V pacing rate (>40%) is anticipated
排除标准
- •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)
研究组 & 干预措施
LBBAP group
In this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.
干预措施: Left bundle branch area pacing (Procedure)
RVP group
In this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed.
干预措施: Right ventricular pacing (Procedure)
结局指标
主要结局
composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy
时间窗: 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).
次要结局
- all cause mortality(during 2 years after pacemaker implantation)
- Cardiovascular mortality(during 2 years after pacemaker implantation)
- LBBAP related complications(during 2 years after pacemaker implantation)
- Rate of LV systolic dysfunction(6month and 2yr after pacemaker implantation)
- LBB capture failure(during 2 years after pacemaker implantation)
- Short-term procedure and Device related complications(during 1wk after pacemaker implantation)
- success rate of LBBAP implantation(during 3days after pacemaker implantation)
- Long-term procedure and Device related complications(during 1wk after pacemaker implantation)
- Changes in cardiopulmonary exercise test parameters(6month and 2yr after pacemaker implantation)
- Heart failure hospitalization(during 2 years after pacemaker implantation)
- Incidental atrial fibrillation(during 2 years after pacemaker implantation)