Home Monitor for AA Burden Detection IIT in TWN (FF108)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Chih-Chieh Yu, MD.PhD
- 電話番号：0972652038
- メール：sweetchieh@gmail.com
研究連絡先のバックアップ
- 名前：HSIAO-HAN HUANG
- 電話番号：0932917553
- メール：clrhuang8853@gmail.com
研究場所
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-
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Taipei、台湾、100
- National Taiwan University Hospita
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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Diagnosed with Paroxysmal Atrial Fibrillation (PAF) or atrial flutter
W who have been implanted or planned to implant with permanent pacemaker device
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
AA burden
時間枠：From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
|
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From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of arrhythmia
時間枠：From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
|
|
From enrollment to the end of treatment at 12-16 months (including periods of screen, treatment, and follow-ups)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 202602039DIPC
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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