About this trial
The present study is a prospective, multicenter, non-inferiority, randomized controlled trail. It aims to investigate whether the efficacy of conduction system pacing (CSP) is non-inferior to biventricular pacing (BiVP) in patients with heart failure and right ventricular pacing (RVP) requiring upgrading to cardiac resynchronization therapy (CRT).
Eligibility criteria
Qualifiers
Patients with symptomatic heart failure (LVEF <50%) after right ventricular pacing for at least 3 months;
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%;
Disqualifiers
History of acute myocardial infarction within 3 months before enrollment;
Frequent premature ventricular contraction (>15%) or malignant ventricular arrhythmia which is difficult to control;
History of valvular heart disease intervention within 3 months before enrollment;
After mechanical tricuspid valve replacement;
Trial design
Treatments tested in this trial
- Conduction system pacing
- Biventricular pacing
Treatment groups
Sponsors and collaborators
The First Affiliated Hospital with Nanjing Medical University
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
The Third Affiliated Hospital of Soochow University
Collaborator
Rugao People's Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Third Affiliated Hospital, Sun Yat-Sen University
Collaborator
Shantou Central Hospital
Collaborator
Meizhou People's Hospital
Collaborator
Changzhou Second People's Hospital affiliated with Nanjing Medical University
Collaborator
Zhangjiagang First People's Hospital
Collaborator
Huizhou Third People's Hospital, Guangzhou Medical University
Collaborator