2021 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy.
Michael Glikson, Jens Cosedis Nielsen, Mads Brix Kronborg...
https://pubmed.ncbi.nlm.nih.gov/34455430Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID06241651
Conduction System Pacing Versus Biventricular Pacing for Heart Failure Patients With Right Ventricular Pacing Upgraded to Cardiac Resynchronization Therapy: a Prospective Multicenter Non-inferiority Randomized Controlled Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-05-14
66
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether conduction system pacing (CSP) is as effective as biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) who need upgrading to cardiac resynchronization therapy (CRT). This prospective, multicenter, randomized controlled trial aims to compare these two pacing methods to see if CSP is not inferior to BiVP in improving heart function. Participants will be randomly assigned to one of two groups. The experimental group will receive CSP lead placement, starting with left bundle branch pacing (LBBP) and switching to His bundle pacing (HBP) if LBBP is unsuccessful. The control group will receive traditional biventricular pacing, involving placement of right atrial, right ventricular, and left ventricular leads using standard techniques. The study will monitor participants over six months to assess treatment effects. During the study, participants will undergo evaluations including echocardiography to measure changes in left ventricular ejection fraction (LVEF), heart size, pacing parameters, and heart function classification. Additional assessments include quality of life questionnaires, walk distance tests, blood markers, and monitoring for adverse events and device-related complications at multiple time points up to six months. The primary outcome is the change in LVEF from baseline to six months after device implantation.
CONDITIONS
Brief Title
CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months
- New York Heart Association (NYHA) class II-IV
- NT-proBNP >125pg/mL in patients with sinus rhythm, NT-proBNP >250pg/mL in patients with atrial fibrillation
- Right ventricular pacing percentage >40%
- Adults aged 18 to 80 years
- Signed informed consent
You will not qualify if you...
- History of acute myocardial infarction within 3 months before enrollment
- Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia difficult to control
- History of valvular heart disease intervention within 3 months before enrollment
- After mechanical tricuspid valve replacement
- Ventricular septal hypertrophy (≥15mm during diastole)
- Complex congenital heart disease
- History of heart transplantation
- Participation in any other study
- Pregnant or planning to become pregnant
- Life expectancy less than 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of device implantation
Participants receive implantation of the assigned pacing device: either conduction system pacing (including attempts of left bundle branch pacing and His bundle pacing) or biventricular pacing using standard techniques.
1 procedural visit (in-person)
Post-operative Follow-up
Duration - 6 months
Participants are monitored for device function, clinical status, and safety through scheduled follow-up visits after device implantation.
Visits 1 day before discharge, and at 1 month, 3 months, and 6 months post-implantation (in-person)
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
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Research Team
J
Jiangang Zou
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
2023 HRS/APHRS/LAHRS guideline on cardiac physiologic pacing for the avoidance and mitigation of heart failure.
Mina K Chung, Kristen K Patton, Chu-Pak Lau...
https://pubmed.ncbi.nlm.nih.gov/37283271The 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/19695453Effect of right ventricular pacing lead site on left ventricular function in patients with high-grade atrioventricular block: results of the Protect-Pace study.
Gerald C Kaye, Nicholas J Linker, Thomas H Marwick...
https://pubmed.ncbi.nlm.nih.gov/25189602Reversal of Pacing-Induced Cardiomyopathy Following Cardiac Resynchronization Therapy.
Shaan Khurshid, Edmond Obeng-Gyimah, Gregory E Supple...
https://pubmed.ncbi.nlm.nih.gov/29749933Beneficial effects of upgrading to His bundle pacing in chronically paced patients with left ventricular ejection fraction <50.
Peiren Shan, Lan Su, Xiaodong Zhou...
https://pubmed.ncbi.nlm.nih.gov/29081396Efficacy of upgrading to left bundle branch pacing in patients with heart failure after right ventricular pacing.
Zhiyong Qian, Yao Wang, Xiaofeng Hou...
https://pubmed.ncbi.nlm.nih.gov/33372293Upgrade of right ventricular pacing to cardiac resynchronization therapy in heart failure: a randomized trial.
Béla Merkely, Robert Hatala, Jerzy K Wranicz...
https://pubmed.ncbi.nlm.nih.gov/37632437