Home Monitor for AA Burden Detection IIT in TWN
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
30 Participants
are grouped into 1 trial groupSponsors and collaborators
National Taiwan University Hospital
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Source ClinicalTrials.gov