Key Factors of Leadless Pacemaker Implantation With Implantation Site, Complications and Prognosis

February 27, 2023 updated by: Yangxin Chen, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Relationship Between Key Factors of Leadless Pacemaker Implantation With Implantation Site, Intraoperative Complications and Prognosis

To investigate the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, we aim to include patients implated with leadless pacemakers, collect key variables and other clinical data during implantation of leadless pacemakers, and observe the final implantation site, intraoperative complications and prognosis information of patients. This study aims to clarify the relationship between key variables in leadless pacemaker implantation with implantation site, intraoperative complications and prognosis, and provide data support for the standardization of leadless pacemaker implantation process in China.

Study Type

Observational

Enrollment (Anticipated)

300

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

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:
        • Principal Investigator:
          • Qi Guo, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients received implantation of leadless pacemaker

Description

Inclusion Criteria:

  • Patient received implantation of leadless pacemaker
  • Patient agreed to join into this study and signed informed consent

Exclusion Criteria:

  • Age < 18 years
  • Ventricular septal defect
  • History of mechanical tricuspid valve replacement
  • History of inferior vena cava filter placement
  • Pregnant or plan to be pregnant within 2 years
  • Life expectancy < 1 year
  • Patient was included in other studies that could introduce bias into this study

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
Measure Description
Time Frame
Serious adverse events
Time Frame: Day 0 (Time of implantation)-Day 7
including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection
Day 0 (Time of implantation)-Day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device-related complications
Time Frame: Day 0 (Time of implantation)-Day 7
Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous fistula, tricuspid valve injury
Day 0 (Time of implantation)-Day 7
Device-related complications
Time Frame: Day 0 (Time of implantation)-Year 2
Femoral venipuncture site hematoma, hemorrhage, pseudoaneurysm, arteriovenous
Day 0 (Time of implantation)-Year 2
Serious adverse events
Time Frame: Day 0 (Time of implantation)-Year 2
including dislodgement (including detachment), cardiac perforation, pericardial effusion, and serious infection
Day 0 (Time of implantation)-Year 2
Re-intervention of devices
Time Frame: Day 0 (Time of implantation)-Year 2
extraction, re-implantation, or implantation of traditional transvenous pacemaker
Day 0 (Time of implantation)-Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

  • Principal Investigator: Yangxin Chen, PhD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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)

October 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Estimate)

March 9, 2023

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SYSKY-2023-056-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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