Following people with paroxysmal atrial fibrillation who have an Amvia pacemaker and home monitoring
Follows people with paroxysmal atrial fibrillation using a pacemaker with home monitoring.
Plain-language title generated from the registry record
Registry title: Home Monitor for AA Burden Detection IIT in TWN
Key facts
- Where
- Hsinchu and Taipei, TaiwanSee the 4 sites
Where in Taiwan
- National Taiwan University Hospital Hsin Chu BranchHsinchu, TaiwanNo longer taking part
- Cathay General HospitalTaipei, TaiwanNo longer taking part
- MacKay Memorial HospitalTaipei, TaiwanNo longer taking part
- National Taiwan University HospitaTaipei, TaiwanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- National Taiwan University Hospital
- Trial code
- NCT07572279
- Record updated
- 7 October 2026
- Original description
Primary Endpoint:Read full original descriptionShow less
The Clinical Follow-Up of the Amvia Pacemaker Family Using Atrial Anti-Tachycardia Pacing (aATP) and Home Monitoring Function in the Patients With Paroxysmal Atrial Fibrillation (PAF)
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
Inclusion: 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: Participation in another prospective interventional clinical study within a period of 4 weeks prior to the implantation of Atrial Arrhythmia; Abnormal baseline findings considered by the investigator to indicate conditions that might affect study endpoints; 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 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; Patients underwent implantable cardioverter-defibrillator implantation.