Taiwan Registry for Leadless Pacemaker

Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.

Study Overview

• Status: Enrolling by invitation
• Conditions: Atrioventricular Block; Sick Sinus Syndrome
• Intervention / Treatment: Device: Leadless Pacemaker

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 (Estimated): 300

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

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 (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Taiwan; Leadless Pacemaker
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Arrhythmia, Sinus; Pathological Conditions, Signs and Symptoms; Atrioventricular Block; Sick Sinus Syndrome
• 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