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Clinical Study of Impact of Different Pacing Site in Patients

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ClinicalTrials.gov Identifier: NCT04931550
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date June 14, 2021
First Posted Date June 18, 2021
Last Update Posted Date January 31, 2023
Actual Study Start Date August 1, 2020
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2021)		 Composite of Cardiovascular death, myocardial infarction, and stroke events [ Time Frame: 60 months ]
Composite of Cardiovascular death, myocardial infarction, and stroke events in 60 months
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Study of Impact of Different Pacing Site in Patients
Official Title Clinical Study of Impact of Different Pacing Site in Patients
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Bradyarrhythmias
  • Heart Failure
  • Pacemaker
Intervention Device: Pacemaker implantation
Different pacing sites will be chosen according to the patients condition.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 14, 2021)		 600
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2026
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xiaohong Pan +8613857116993 heartpanxh@zju.edu.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04931550
Other Study ID Numbers Y2020-675
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Responsible Party Same as current
Current Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date January 2023