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
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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%;
• Adult patients aged 18-80;
• With informed consent signed.
Locations
Other Locations
China
The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Jiangang Zou
jgzou@njmu.edu.cn
86-13605191407
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 66
Treatments
Experimental: CSP group
In this group, CSP lead is attempted to be placed, including LBBP and HBP.
Active_comparator: BiVP group
In this group, traditional RA lead , RV lead and LV lead are attempted to be placed.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Hospital of Xuzhou Medical University, Shantou Central Hospital, First Affiliated Hospital, Sun Yat-Sen University, Changzhou Second People's Hospital affiliated with Nanjing Medical University, Third Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Huizhou Third People's Hospital, Guangzhou Medical University, Meizhou People's Hospital, The Third Affiliated Hospital of Soochow University, Rugao People's Hospital, The First Affiliated Hospital of Soochow University, Zhangjiagang First People's Hospital
Leads: The First Affiliated Hospital with Nanjing Medical University