Clinical Study of Impact of Different Pacing Site in Patients

Heart Failure Clinical Trial

Official title:

Clinical Study of Impact of Different Pacing Site in Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931550
• Other study ID #: Y2020-675
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 2026

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, different sites can be chosen to pace, such as right atrial appendage, the atrial septum and the right atrial wall in the atrium, His bundle, left bundle branch area, right ventricular apex, outflow tract, and left ventricular pacing via coronary vein in the ventricle. There are few studies comparing the long-term efficacy and safety of different pacing sites in daily practice. This study aims to observe the efficacy and safety of cardiac pacing at different sites in short and long term, and to compare the advantages and disadvantages of pacing at different sites.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2026
• Est. primary completion date: December 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
• Pacemaker

Intervention

Device:
• Pacemaker implantation
Different pacing sites will be chosen according to the patients condition.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	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	Composite of Cardiovascular death, myocardial infarction, and stroke events in 60 months	60 months