Atrial Flutter, Paroxysmal Atrial Fibrillation (PAF)
Conditions
Keywords
Paroxysmal Atrial Fibrillation, atrial flutter, permanent pacemaker device, Home Monitoring technology
Brief 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
Detailed description
This prospective observational single-arm, open-label, non-randomized, multi-center study to evaluate the impact of advanced remote monitoring technologies and features, such as the aATP function of BIOTRONIK pacemakers, in conjunction with wireless monitoring via the CardioMessenger 4G or its successors. The study population will consist of patients diagnosed with PAF or atrial flutter who will be/have been implanted with permanent pacemaker devices and CardioMessenger Smart Home Monitoring before joining the study. Eligible patients will be enrolled through the process of informed consent in the clinical investigational sites across Taiwan with competitive enrollment. All subjects enrolled in the study will use aATP and HM function of BIOTRONIK pacemakers. During the screen period, the subject's medical history and demographic information will be collected. The baseline data will be obtained prior to the pacing implantation. Depending on the needs of the subject, the screen and implantation procedures may be performed on the same day (within 12 weeks of baseline). Implant data will include features of aATP function, implant technique, and lead positioning. After completion of pacemaker implantation, subjects will be followed at 3, 6, and 12 months or until patient withdrawal or death. During follow-up, a determination/evaluation will be performed based on the data collection from the device system. Unscheduled visit will be arranged after investigator evaluated patient's data via HMSC and judged the clinic visit is needed. With BIOTRONIK Home Monitoring, medical and technical data is sent from the implanted device to the CardioMessenger. This data is then forwarded to the BIOTRONIK Home Monitoring Service Center via the cellular telephone network. Investigators who monitor subjects implanted device can review this data from the Home Monitoring Service Center website (HMSC website). In the study, subject demographics (age, gender, height, weight, etc.) and comorbidities will be collected during the screen period. Implant procedure details and pacing parameters will be recorded. Both primary and secondary endpoints will be collected and evaluated at baseline and follow-up periods.
Interventions
None listed
Sponsors
National Taiwan University Hospital
Biotronik SE & Co. KG
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AA burden | From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups) | * Early detection rate in Atrial Arrhythmia (AA) burden * Data transmission success rate for overall number of atrial burden collection during the monitoring period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of arrhythmia | From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups) | * 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 |
Countries
Taiwan
Contacts
CONTACTChih-Chieh Yu, MD.PhD
CONTACTHSIAO-HAN HUANG
Outcome results
None listed