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

4 mai 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Nom: Chih-Chieh Yu, MD.PhD
Numéro de téléphone: 0972652038
E-mail: sweetchieh@gmail.com

Sauvegarde des contacts de l'étude

Nom: HSIAO-HAN HUANG
Numéro de téléphone: 0932917553
E-mail: clrhuang8853@gmail.com

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La 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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Nombre de groupes / cohortes

Cohortes et interventions

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

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats	Description de la mesure	Délai
AA burden Délai: 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)

Mesures de résultats secondaires

Mesure des résultats	Description de la mesure	Délai
Incidence of arrhythmia Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Taiwan University Hospital

Collaborateurs

Biotronik SE & Co. KG

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

31 décembre 2030

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

28 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 mai 2026

Première publication (Réel)

7 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)