Home Monitor for AA Burden Detection IIT in TWN (FF108)

May 4, 2026 updated by: National Taiwan University Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospita

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter who have been implanted or planned to implant with permanent pacemaker device

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter
W who have been implanted or planned to implant with permanent pacemaker device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AA burden
Time Frame: 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
From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of arrhythmia
Time Frame: 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
From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Biotronik SE & Co. KG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202602039DIPC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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