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

4 maj 2026 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

30

Kontakter och platser

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Studiekontakt

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Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
AA burden
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of arrhythmia
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Taiwan University Hospital

Samarbetspartners

Biotronik SE & Co. KG

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

31 december 2030

Avslutad studie (Beräknad)

31 december 2030

Studieregistreringsdatum

Först inskickad

28 april 2026

Först inskickad som uppfyllde QC-kriterierna

4 maj 2026

Första postat (Faktisk)

7 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 202602039DIPC

Plan för individuella deltagardata (IPD)

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Nej

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Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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