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
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