- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919447
Clinical Study of LBBP
January 29, 2023 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
Study of the Efficacy and Safety of Cardiac Pacing of Different Sites
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
540
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xiaohong Pan
- Phone Number: +8613857116993
- Email: heartpanxh@zju.edu.cn
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310000
- Recruiting
- Xiaohong Pan
-
Contact:
- Xiaohong Pan
- Phone Number: +8613857116993
- Email: heartpanxh@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of Cardiovascular death, myocardial infarction, and stroke events
Time Frame: 60 months
|
60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2021
Primary Completion (Anticipated)
August 1, 2025
Study Completion (Anticipated)
August 1, 2025
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 8, 2021
First Posted (Actual)
June 9, 2021
Study Record Updates
Last Update Posted (Actual)
January 31, 2023
Last Update Submitted That Met QC Criteria
January 29, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-675
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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