Clinical Study of LBBP

Heart Failure Clinical Trial

Official title:

Study of the Efficacy and Safety of Cardiac Pacing of Different Sites

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04919447
• Other study ID #: 2020-675
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 2025

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiaohong Pan
• Phone: +8613857116993
• Email: heartpanxh[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

At present, cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients. With the rapid development of technology, you can choose to pace the heart in different parts. The atrium can choose the right atrial appendage, the atrial septum and the right ventricular side wall. The right ventricle can choose to be paced in the His bundle, right ventricular apex and ventricular septal outflow tract. The right ventricle can choose the pacing positions including left bundle branch pacing and left ventricular pacing via coronary vein. There are few studies comparing the long-term efficacy and safety of different pacing programs in daily practice. This study is to observe the short-term and long-term effects and safety of different parts of cardiac pacing, and compare the advantages and disadvantages of different parts of cardiac pacing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who received pacemaker implantation in the Second Hospital of Zhejiang Medical University by Pan Xiaohong and other surgeons.

• Patients who have the ability to understand the test and can cooperate with investigators.

Exclusion Criteria:

• Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors

Related Conditions & MeSH terms

• Bradyarrhythmias
• Bradycardia
• Heart Failure

Intervention

Procedure:
• pacemaker implantation
cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients.

Locations

Country	Name	City	State
China	Xiaohong Pan	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Cardiovascular death, myocardial infarction, and stroke events		60 months