CSP Versus BiVP for Heart Failure Patients With RVP Upgraded to Cardiac Resynchronization Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital with Nanjing Medical University

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

66 Participants
are divided into 2 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