NCT04926792

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
33mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jan 2022Dec 2028

First Submitted

Initial submission to the registry

June 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

January 19, 2022

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

7 years

First QC Date

June 9, 2021

Last Update Submit

January 6, 2026

Conditions

Sick Sinus SyndromeAtrioventricular Block

Keywords

Leadless PacemakerTaiwan

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Successful implant

    1 day

Interventions

Leadless PacemakerDEVICE

Leadless pacemaker implantation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

who attempt or had successfully received a leadless pacemaker implantation

You may qualify if:

  • The patients who had successfully received leadless pacemaker implantation
  • The patients who attempt to receive leadless pacemaker implantation

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Sick Sinus SyndromeAtrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmia, SinusArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesHeart BlockCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chih-Chieh Yu, MD.PhD

    Taiwan Society of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 15, 2021

Study Start

January 19, 2022

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)