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

Status: Enrolling

Conditions: Atrioventricular Block; Bradyarrhythmia; Left Bundle Branch Area Pacing

Treatments: Procedure: Right ventricular pacing; Procedure: Left bundle branch area pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT05585411

4-2022-0824

Details and patient eligibility

About

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%).

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

450 participants in 2 patient groups

LBBAP group

Experimental group

Description:

In this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.

Treatment:

Procedure: Left bundle branch area pacing

RVP group

Active Comparator group

Description:

In this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed.

Treatment:

Procedure: Right ventricular pacing