Paroxysmal Atrial Fibrillation (PAF)FF108NCT07572279
Home Monitor for AA Burden Detection IIT in TWN
An observational study of Paroxysmal Atrial Fibrillation (PAF) and Atrial Flutter, run by National Taiwan University Hospital at 4 sites in Taiwan.
Trial 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)… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation (PAF), Atrial Flutter
- How many people
- 30 participants
- Where
- 4 sitesTaiwan
- Study dates
- 1 Dec 2026to 31 Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan4 sites
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu
AN-LI YU, (03)6677600, foxxfelicity@gmail.com
National Taiwan University Hospita
Taipei, 100
Cathay General Hospital
Taipei
SHIH-YU HUANG, Cathay General Hospital, Bathchen6121@gmail.com
MacKay Memorial Hospital
Taipei
YIN-HSIANG LI, (02) 2543-3535, tocss629@yahoo.com.tw
About this study
Official title: The Clinical Follow-Up of the Amvia Pacemaker Family Using Atrial Anti-Tachycardia Pacing (aATP) and Home Monitoring Function in the Patients With Paroxysmal Atrial Fibrillation (PAF)
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
Read the 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.
- Keywords
- Paroxysmal Atrial Fibrillation, atrial flutter, permanent pacemaker device, Home Monitoring technology
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter | W who have been implanted or planned to implant with permanent pacemaker device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal Atrial Fibrillation (PAF)Studies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Biotronik SE & Co. KG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07572279
- Sponsor's protocol ID
- 202602039DIPC
- Acronym
- FF108
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided