The effects of right ventricular apical pacing on ventricular function and dyssynchrony implications for therapy.
Laurens F Tops, Martin J Schalij, Jeroen J Bax
https://pubmed.ncbi.nlm.nih.gov/19695453Actively Recruiting
Phase Not Applicable
Age: 19Years +
All Genders
ID05585411
Preventive Effect of Left Bundle Branch Area Pacing Versus Right Ventricular Pacing on Death, Heart Failure Progression, and Ventricular Dyssynchrony in Patients With Substantial Ventricular Pacing: PROTECT-SYNC Multicenter Randomized Controlled Trial
Led by Yonsei University · Updated on 2026-01-05
450
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating clinical outcomes in patients with bradyarrhythmia who require a high amount of ventricular pacing (over 40%). This trial compares Left Bundle Branch Area Pacing (LBBAP) with Right Ventricular Pacing (RVP) to see if LBBAP reduces risks such as death, heart failure progression, pacing-induced cardiomyopathy, and the need for cardiac resynchronization therapy. The study is conducted across seven medical centers in the Republic of Korea with a total enrollment of 450 patients. Patients needing a pacemaker and significant ventricular pacing will be randomly assigned to receive either LBBAP or RVP. In the LBBAP group, a specialized lead is placed at the left bundle branch area of the heart, while in the RVP group, the lead is placed in the right ventricle using standard methods. The study includes a 2-year enrollment period followed by 2 years of patient follow-up to assess outcomes. Participants will undergo pacemaker implantation and then be monitored for 2 years, with evaluations including death rates, heart failure hospitalizations, device complications, and heart function tests. Success rates and complications related to LBBAP are tracked, along with measurements of left ventricular function and exercise capacity. Researchers will also monitor for incidental atrial fibrillation and other cardiovascular events during follow-up.
CONDITIONS
Brief 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
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- At least 19 years old and able to give informed consent
- Willing and able to comply with follow-up tests and schedules
- Scheduled to receive a pacemaker implant
- Expected to require more than 40% ventricular pacing
You will not qualify if you...
- Incapacitated or unable to read or write
- Indication for ICD or cardiac resynchronization therapy
- History of prosthetic valve surgery on the tricuspid valve
- Prior myocardial infarction including ventricular septum
- Life expectancy less than 12 months
- Unable to attend follow-up visits for at least 24 months
- Pregnant or breastfeeding at consent
- Prior heart transplant surgery
- Presence of persistent left superior vena cava (PLSVC)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Procedure day plus initial recovery period
Participants receive either left bundle branch area pacing (LBBAP) or right ventricular pacing (RVP) as part of their pacemaker implantation procedure.
1 baseline implantation visit and approximately 1 week of monitoring visits
Follow-up
Duration - Up to 2 years
Participants are monitored for up to 2 years after pacemaker implantation to assess health outcomes, device success, and any complications.
Multiple follow-up visits over 2 years, including assessments at 6 months and 2 years
Trial Site Locations
Total: 8 locations
1
Bucheon Sejong Hospital
Bucheon-si, South Korea
Actively Recruiting
2
GyeongSang National University Changwon Hospital
Changwon, South Korea
Actively Recruiting
3
Chungbuk National University Hospital
Chungju, South Korea
Actively Recruiting
4
Asan Medical Center
Seoul, South Korea
Actively Recruiting
5
Kyunghee University hospital
Seoul, South Korea
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
7
Seoul Saint Mary's Hospital
Seoul, South Korea
Actively Recruiting
8
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Not Yet Recruiting
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Research Team
T
TaeHoon Kim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Long-term effect of right ventricular pacing on myocardial perfusion and function.
H F Tse, C P Lau
https://pubmed.ncbi.nlm.nih.gov/9091519Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction.
Michael O Sweeney, Anne S Hellkamp, Kenneth A Ellenbogen...
https://pubmed.ncbi.nlm.nih.gov/12782566Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial.
Bruce L Wilkoff, James R Cook, Andrew E Epstein...
https://pubmed.ncbi.nlm.nih.gov/12495391Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing.
Mohamed Abdelrahman, Faiz A Subzposh, Dominik Beer...
https://pubmed.ncbi.nlm.nih.gov/295350662018 ACC/AHA/HRS Guideline on the Evaluation and Management of Patients With Bradycardia and Cardiac Conduction Delay: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society.
Fred M Kusumoto, Mark H Schoenfeld, Coletta Barrett...
https://pubmed.ncbi.nlm.nih.gov/305867722021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.
Michael Glikson, Jens Cosedis Nielsen, Mads Brix Kronborg...
https://pubmed.ncbi.nlm.nih.gov/34455430Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block.
Weijian Huang, Lan Su, Shengjie Wu...
https://pubmed.ncbi.nlm.nih.gov/30093543Left Bundle Branch Area Pacing for Cardiac Resynchronization Therapy: Results From the International LBBAP Collaborative Study Group.
Pugazhendhi Vijayaraman, ShunmugaSundaram Ponnusamy, Óscar Cano...
https://pubmed.ncbi.nlm.nih.gov/33602393Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry.
Parikshit S Sharma, Neil R Patel, Venkatesh Ravi...
https://pubmed.ncbi.nlm.nih.gov/34481985