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

Summary

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).

Conditions

• Conduction System Pacing
• Biventricular Pacing
• Cardiac Resynchronization Therapy
• Right Ventricular Pacing
• Heart Failure

Interventions

DEVICE

Conduction system pacing

Firstly, we will attempt LBBP if the patient is allocated to the experimental group. If we can not achieve LBBP successfully, then we will turn to attempt HBP.

DEVICE

Biventricular pacing

Implantation of RA lead, RV lead and LV lead are attempted using the standard-of-care technique.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Soochow University

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Soochow University

  collaborator OTHER

• Rugao People's Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shantou Central Hospital

  collaborator OTHER

• Meizhou People's Hospital

  collaborator OTHER

• Changzhou Second People's Hospital affiliated with Nanjing Medical University

  collaborator OTHER

• Zhangjiagang First People's Hospital

  collaborator OTHER

• Huizhou Third People's Hospital, Guangzhou Medical University

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-01

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• China

Study Locations