Taiwan Registry for Leadless Pacemaker

• Conditions: Atrioventricular Block; Sick Sinus Syndrome

• Registration Number: NCT04926792
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-15
• Study Start: 2022-01-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Successful implant	1 day	The attempts of deployment in one procedure

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan