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

4. mai 2026 oppdatert 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

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

30

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AA burden
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of arrhythmia
Tidsramme: 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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Taiwan University Hospital

Samarbeidspartnere

Biotronik SE & Co. KG

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

28. april 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

7. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 202602039DIPC

Plan for individuelle deltakerdata (IPD)

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UBESLUTTE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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