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

4 mei 2026 bijgewerkt door: 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

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Geschat)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Chih-Chieh Yu, MD.PhD
Telefoonnummer: 0972652038
E-mail: sweetchieh@gmail.com

Studie Contact Back-up

Naam: HSIAO-HAN HUANG
Telefoonnummer: 0932917553
E-mail: clrhuang8853@gmail.com

Studie Locaties

Taiwan
- - Taipei, Taiwan, 100
    - National Taiwan University Hospita

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Volwassen
Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
AA burden Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Incidence of arrhythmia Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Taiwan University Hospital

Medewerkers

Biotronik SE & Co. KG

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

31 december 2030

Studie voltooiing (Geschat)

31 december 2030

Studieregistratiedata

Eerst ingediend

28 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

4 mei 2026

Eerst geplaatst (Werkelijk)

7 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)