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

4. maj 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Taiwan University Hospital

Samarbejdspartnere

Biotronik SE & Co. KG

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. december 2030

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

28. april 2026

Først indsendt, der opfyldte QC-kriterier

4. maj 2026

Først opslået (Faktiske)

7. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 202602039DIPC

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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