Home Monitor for AA Burden Detection IIT in TWN

Starting soon

Conditions studied: Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter

In brief

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

Key facts

Study ID

NCT07572279

Run by

National Taiwan University Hospital

People needed

30

Starts

2026-06-01

Expected to finish

2030-12-31

Last updated by the study team

2026-05-07

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• National Taiwan University Hospita — Taipei, Taiwan

Full record on ClinicalTrials.gov

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