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RecruitingNCT04919447Updated Jan 31, 2023

Clinical Study of LBBP

An observational study in Bradyarrhythmias and Heart Failure, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-01-31.

Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
540
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bradyarrhythmias
  • Heart Failure

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03

In context

Bradycardia

306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.

This study's planned enrollment of 540 is above the median of 257 across 129 observational studies indexed under Bradycardia.

Browse Bradycardia studies →

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Patients who unable to understand or unwilling to fill in informed consent forms or follow visitors
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
540 participants (estimated)
Patient registry
No

Interventions

  • Procedurepacemaker implantation

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

06

What researchers measure

Primary outcomes

  1. Composite of Cardiovascular death, myocardial infarction, and stroke events

    Time frame: 60 months

07

Study locations

1 of 1 sites recruiting
  • Xiaohong Pan
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04919447
Lead sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Jun 9, 2021
Start date
Jun 1, 2021
Primary completion
Aug 2025 (estimated)
Completion
Aug 2025 (estimated)
Last update
Jan 31, 2023

Study contacts

Xiaohong Pan
Contact
heartpanxh@zju.edu.cn
+8613857116993

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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