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