Clinical Study of LBBP

NCT04919447 | Unknown

• 1 other identifier: 2020-675
• Study Type: observational
• Target: 540
• 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, 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.

Conditions

Bradyarrhythmias; Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  60 months

Interventions

pacemaker implantation PROCEDURE

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

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)

Xiaohong Pan

Hangzhou, Zhejiang, 310000, 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 7, 2021
• First Posted: June 9, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (1)