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Not Yet Recruiting NCT07572279

Home Monitor for AA Burden Detection IIT in TWN

Conditions: Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter

Sex: All
Ages: 20 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: National Taiwan University Hospital

Location: National Taiwan University Hospital Hsin-Chu Branch Hsinchu

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

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07572279). StuddyBuddy aggregates publicly available trial information.