Clinical Study of LBBP

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04919447
Collaborator
(none)
540
1
50
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: pacemaker implantation

Study Design

Study Type:
Observational
Anticipated Enrollment :
540 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of the Efficacy and Safety of Cardiac Pacing of Different Sites
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Aug 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Composite of Cardiovascular death, myocardial infarction, and stroke events [60 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiaohong Pan Hangzhou Zhejiang China 310000

Sponsors and Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier:
NCT04919447
Other Study ID Numbers:
  • 2020-675
First Posted:
Jun 9, 2021
Last Update Posted:
Jun 9, 2021
Last Verified:
Jun 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2021