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.
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
- Are there results?
- Not yet: the study is under way
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.
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.
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block
- 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.
Acute complication
Any acute complication during procedure
Measured: On the 1 day of implant procedure
Subacute complication
Any subacute complication, including pacemaker syndrome
Measured: within 3 month after implant procedure
Leadless Pacemaker performance
The AV synchrony or pacemaker parameters
Measured: aroung 12 months after implant proceure
Secondary outcomes (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.
- First posted15 Jun 2021
- Study start19 Jan 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sick Sinus SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Taiwan Society of Cardiology, Chang Gung Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Chih-Chieh Yu, MD.PhD, Principal investigator, Taiwan Society of Cardiology
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taiwan Registry for Leadless Pacemaker
- ClinicalTrials.gov ID
- NCT04926792
- Acronym / sponsor ID
- 202103105RINB
- Conditions
- Sick Sinus Syndrome, Atrioventricular Block
- Keywords
- Leadless Pacemaker, Taiwan
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Taiwan Society of Cardiology, Chang Gung Memorial Hospital
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- who attempt or had successfully received a leadless pacemaker implantation
Key inclusion criteria (2 listed)
- The patients who had successfully received leadless pacemaker implantation
- The patients who attempt to receive leadless pacemaker implantation
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leadless PacemakerLeadless pacemaker implantation | Device | – |
Primary outcome
Acute complication
Time frame: On the 1 day of implant procedure
Any acute complication during procedure
Subacute complication
Time frame: within 3 month after implant procedure
Any subacute complication, including pacemaker syndrome
Leadless Pacemaker performance
Time frame: aroung 12 months after implant proceure
The AV synchrony or pacemaker parameters
1 secondary outcome
Successful implant
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chih-Chieh Yu, MD.PhD principal investigator
Taiwan Society of Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sick Sinus Syndrome and Atrioventricular Block, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute complication (time frame: On the 1 day of implant procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.