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
This trial does not accept healthy volunteersQualifiers
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 population
Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter
Trial outcomes
Primary outcomes
1
AA burden
* Early detection rate in Atrial Arrhythmia (AA) burden * Data transmission success rate for overall number of atrial burden collection during the monitoring period
Time frame
From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)Secondary outcomes
1
Incidence of arrhythmia
* 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
Time frame
From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Biotronik SE & Co. KG
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: