Taiwan Registry for Leadless Pacemaker

April 17, 2023 updated by: National Taiwan University Hospital
Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The purpose of this registry is to investigate the safety and efficiency performance of the leadless pacemakers in Taiwan. The registry will collect all the information about the patient selection, implantation procedure, and follow up parameters of the leadless pacemakers to evaluate the real-world benefit specifically in Taiwan population.

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 Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

who attempt or had successfully received a leadless pacemaker implantation

Description

Inclusion Criteria:

  1. The patients who had successfully received leadless pacemaker implantation
  2. The patients who attempt to receive leadless pacemaker implantation

Exclusion Criteria:

N/A

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
Acute complication
Time Frame: On the 1 day of implant procedure
Any acute complication during procedure
On the 1 day of implant procedure
Subacute complication
Time Frame: within 3 month after implant procedure
Any subacute complication, including pacemaker syndrome
within 3 month after implant procedure
Leadless Pacemaker performance
Time Frame: aroung 12 months after implant proceure
The AV synchrony or pacemaker parameters
aroung 12 months after implant proceure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful implant
Time Frame: 1 day
The attempts of deployment in one procedure
1 day

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Collaborators

Chang Gung Memorial Hospital
Taiwan Society of Cardiology

Investigators

  • Principal Investigator: Chih-Chieh Yu, MD.PhD, Taiwan Society of Cardiology

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)

January 19, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202103105RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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