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

Launched by YONSEI UNIVERSITY · Oct 14, 2022

Keywords

ClinConnect Summary

The PROTECT-SYNC trial is a research study looking at two different ways to pace the heart in patients with a condition called bradyarrhythmia, where the heart beats too slowly. Specifically, the study compares a method called Left Bundle Branch Area Pacing (LBBAP) to the more traditional Right Ventricular Pacing (RVP). Researchers want to find out which method helps patients live longer, reduces the progression of heart failure, and improves heart function. The study will involve 450 participants over two years, and each participant will be followed for an additional two years to see how they do.

To be eligible for this trial, participants need to be at least 19 years old and able to give their consent to participate. They should be scheduled to receive a pacemaker implant and have a significant need for ventricular pacing (more than 40% of the time). However, there are some criteria that would exclude someone from participating, such as having certain heart conditions, a history of significant heart surgeries, or being pregnant. If you choose to participate, you can expect regular follow-up visits and tests to monitor your health and the effectiveness of the pacing method you receive.

Gender

ALL

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)