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
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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%).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Bucheon Sejong Hospital
RECRUITING
Bucheon-si
GyeongSang National University Changwon Hospital
RECRUITING
Changwon
Chungbuk National University Hospital
RECRUITING
Chungju
Asan Medical Center
RECRUITING
Seoul
Kyunghee University hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Seoul Saint Mary's Hospital
RECRUITING
Seoul
Yonsei University Health System, Severance Hospital
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
TaeHoon Kim
thkimcardio@yuhs.ac
+82 02-2228-8467
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 450
Treatments
Experimental: LBBAP group
In this arm, a left bundle branch area pacing(LBBAP) lead will be attempted to be placed.
Active_comparator: RVP group
In this arm, a Right ventricular pacing (RVP) lead will be attempted to be placed.
Related Therapeutic Areas
Sponsors
Leads: Yonsei University