Taiwan Registry for Leadless Pacemaker (NCT04926792) | Clinical Trial Compass
By InvitationNot Applicable
Taiwan Registry for Leadless Pacemaker
Taiwan300 participantsStarted 2022-01-19
Plain-language summary
Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The patients who had successfully received leadless pacemaker implantation
. The patients who attempt to receive leadless pacemaker implantation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an invitation-only registry, can you tell me whether I would even be considered for this, and what criteria are being used to invite patients with sick sinus syndrome or atrioventricular block like mine?
2This study is tracking acute and subacute complications with the leadless pacemaker — what kinds of complications have been seen so far in other leadless pacemaker studies, and how does that compare to getting a traditional pacemaker with leads?
3Since this is a registry rather than a randomized trial, does that mean it's mainly collecting data on how the leadless pacemaker performs in real-world use in Taiwan, rather than testing whether it works better than something else — and how does that affect what I'd gain by participating?
4Would you recommend the leadless pacemaker as the right choice for my specific type of heart rhythm problem right now, or is a conventional pacemaker still considered the standard approach for my condition?
5What would my follow-up schedule look like if I were part of this registry, and are there any additional visits or monitoring requirements beyond what I'd have with normal pacemaker care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute complication
Timeframe: On the 1 day of implant procedure
2
Subacute complication
Timeframe: within 3 month after implant procedure
3
Leadless Pacemaker performance
Timeframe: aroung 12 months after implant proceure