Home Monitor for AA Burden Detection IIT in TWN (NCT07572279) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Home Monitor for AA Burden Detection IIT in TWN
Taiwan30 participantsStarted 2026-06-01
Plain-language summary
Primary Endpoint:
* Early detection rate in Atrial Arrhythmia (AA) burden
* Data transmission success rate for overall number of atrial burden collection during the monitoring period
Secondary Endpoints:
* Atrial burden occurrence at 3/6/12 months post-aATP
* Incidence of arrhythmia
* Safety: Immediate (\< 24 hours), in-hospital, 3 months, 6 months and 12 months adverse events
Who can participate
Age range
20 Years
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:
* Adult patients ≥ 20 years of age
* Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device
* The diagnosis of AF is confirmed on a 12-lead electrocardiogram (ECG) or lasting \>30 seconds in single lead ECG monitor
* Implanted within 12 weeks prior to enrollment or being considered for implantation of a PPM with Home Monitoring technology
* Able to give informed consent for the participation in the trial
Exclusion Criteria:
* Patients are not able to use CardioMessenger 4G or its successors
* Life expectancy \< 1 year
* Sepsis
* Long-standing Persistent Atrial Fibrillation or Permanent Atrial Fibrillation
* Pregnant or breast-feeding women
* Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints
* Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of Atrial Arrhythmia
* Present or history of drug addiction
* Any other condition that, in the investigator's judgment, might increase the risk to the patients or affect trial quality
* Patients underwent implantable cardioverter-defibrillator 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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
AA burden
Timeframe: From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)