Clinical trial NCT05585411: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bradyarrhythmia
Atrioventricular Block
Left Bundle Branch Area Pacing
Keywords: Left Bundle Branch Area pacing
Right Ventricular Pacing
Heart Failure
Atrioventricular block
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 450
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. At least 19 years old and willing and capable to give informed consent
2. 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:

1. Incapacitated or unable to read or write
2. Patient who is an indication of ICD or CRT
3. History of prosthetic valve surgery on tricuspid valve
4. Prior myocardial infarction including ventricular septum
5. Life expectancy \< 12 months due to any condition
6. Unavailable for at least 24 months of follow-up visits
7. Pregnant or breastfeeding at the time of signing consent
8. Prior Heart transplant surgery
9. Persistent Left Superior Vena Cava (PLSVC)

Primary outcomes:
measure: composite of all-cause death, heart failure hospitalization, occurrence of pacing induced cardiomyopathy, and an upgrade to cardiac resynchronization therapy
timeFrame: during 2 years after pacemaker implantation
Secondary outcomes:
measure: all cause mortality
timeFrame: during 2 years after pacemaker implantation
measure: Cardiovascular mortality
timeFrame: during 2 years after pacemaker implantation
measure: Heart failure hospitalization
timeFrame: during 2 years after pacemaker implantation
measure: success rate of LBBAP implantation
timeFrame: during 3days after pacemaker implantation
measure: LBBAP related complications
timeFrame: during 2 years after pacemaker implantation
measure: LBB capture failure
timeFrame: during 2 years after pacemaker implantation
measure: Short-term procedure and Device related complications
timeFrame: during 1wk after pacemaker implantation
measure: Long-term procedure and Device related complications
timeFrame: during 1wk after pacemaker implantation
measure: Rate of LV systolic dysfunction
timeFrame: 6month and 2yr after pacemaker implantation
measure: Changes in cardiopulmonary exercise test parameters
timeFrame: 6month and 2yr after pacemaker implantation
measure: Incidental atrial fibrillation
timeFrame: during 2 years after pacemaker implantation
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Changwon
country: Korea, Republic of
facility: GyeongSang National University Changwon Hospital
city: Chungju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyunghee University hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Severance Cardiovascular Hospital Yonsei University
name: TaeHoon Kim
role: PRINCIPAL_INVESTIGATOR
References:
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