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Sick Sinus SyndromeNCT04926792

Taiwan Registry for Leadless Pacemaker

An observational study of Sick Sinus Syndrome and Atrioventricular Block, run by National Taiwan University Hospital at 1 site in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial summary

Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan. Read more about this study

Who is it for?
Any age
Conditions the study is for
Sick Sinus Syndrome, Atrioventricular Block
What is being tested?
Leadless Pacemaker
Type of treatment
Medical device
How many people
300 participants
Where
1 siteTaiwan
Study dates
19 Jan 2022to 31 Dec 2028
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: who attempt or had successfully received a leadless pacemaker implantation

Who may be able to join

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

Who cannot join

  • N/A

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei

Other trials in Taiwan

About this study

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

Read the 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.

Being tested
Leadless Pacemaker
Keywords
Leadless Pacemaker, Taiwan
Medical subject headings
Sick Sinus Syndrome, Atrioventricular Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Leadless PacemakerDevice

    Leadless pacemaker implantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute complication

    Any acute complication during procedure

    Measured: On the 1 day of implant procedure

  2. Subacute complication

    Any subacute complication, including pacemaker syndrome

    Measured: within 3 month after implant procedure

  3. Leadless Pacemaker performance

    The AV synchrony or pacemaker parameters

    Measured: aroung 12 months after implant proceure

Secondary outcomes (1)
  1. Successful implant

    The attempts of deployment in one procedure

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start19 Jan 2022
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926792
Sponsor's protocol ID
202103105RINB
Status last verified
Jan 2026
First submitted
9 Jun 2021
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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