Clinical Study of Impact of Different Pacing Site in Patients

NCT04931550 | Recruiting

• 1 other identifier: Y2020-675
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bradyarrhythmias; Heart Failure; Pacemaker

Outcome Measures

Primary Outcomes (1)

• Composite of Cardiovascular death, myocardial infarction, and stroke events

  Composite of Cardiovascular death, myocardial infarction, and stroke events in 60 months

  60 months

Interventions

Pacemaker implantation DEVICE

Different pacing sites will be chosen according to the patients condition.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the current reports and the researcher's pacing implantation status, with an enrollment rate of 90% and a loss of follow-up rate of 10%, it is estimated that 600 cases were screened, 540 cases were selected, and about 500 cases were effective.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Bradycardia; Heart Failure

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Xiaohong Pan

CONTACT

+8613857116993; heartpanxh@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: June 18, 2021
• Study Start: August 1, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)