Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan (J-HomeCARE II)
Monitoring of Fluid Status in Heart Failure Patients by Intrathoracic Impedance Measurement in Japan
調査の概要
詳細な説明
The new BIOTRONIK ICD family Lumax 540 is capable of measuring the intrathoracic impedance on a daily basis and transmission of impedance trend data via the Home Monitoring technology. In future, this will allow for automatic early detection of imminent decompensation at a presymptomatic stage and immediate initialization of clinical meaningful therapeutic interventions preventing heart failure related hospitalizations. The aim of this investigation is to record long-term impedance trends in heart failure patients with and without HF related events (hospitalizations due to acute decompensation) in order to develop algorithms for device-based early detection and warning of HF deterioration accompanied by pulmonary congestion.
Lumax is the name of a family of implantable ICDs. The primary objective of the therapy is the prevention of sudden cardiac death. The aim is to automatically detect and terminate cardiac arrest caused by ventricular tachyarrhythmia. All major therapeutical approaches from the field of cardiology and electrophysiology are contained within the Lumax family.
Furthermore, the device is capable of treating bradycardia arrhythmias and congestive heart failure. Congestive heart failure is treated with cardiac resynchronization therapy with multisite ventricular pacing known as cardiac resynchronization therapy (CRT).
The integrated Home Monitoring component can provide information about occurring rhythm disturbances and delivered therapies close to real time as well as by intracardiac electrogram (IEGM) Online HD®. Furthermore, statistical data about the patient's condition as well as information about the integrity status of the implant itself are sent.
The implantation of an ICD is a symptomatic therapy with the following objectives:
Termination of spontaneous ventricular fibrillation (VF) through shock delivery Termination of spontaneous ventricular tachycardia (VT) by means of antitachycardia pacing (ATP); in case of ineffective ATP or hemodynamically not tolerated VT with shock delivery Cardiac resynchronization by multisite ventricular pacing (triple-chamber implant) Compensation of bradycardia through ventricular (single-chamber implant) or atrioventricular sequential pacing (dual- and triple-chamber implant)
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Hiroshima、日本
- Hiroshima Shimin Hospital
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Tokyo、日本
- Tokyo Women's Medical University
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Fukuoka
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Kitakyushu、Fukuoka、日本、802-8555
- Kokura Kinen Hospital
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Mie
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Ise、Mie、日本、516-0805
- Yamada Red Cross Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient eligible for 1-, 2- or 3-chamber ICD implantation according to current guidelines or patient already implanted with a Lumax 540 device or successor
- New York Heart Association (NYHA)-class II to IV
- Left ventricular ejection fraction (LVEF) lower or equal to 35%
- Patient accepts Home Monitoring concept and has sufficient Global System for Mobile Communications (GSM) /General Packet Radio Service (GPRS) net coverage
- Increased risk for HF-related hospitalization according to pre-defined criteria
- Patient information
- Informed consent
Exclusion Criteria:
- Age < 18 years
- Contraindication for ICD implantation
- Post heart transplant (HTX) or actively listed for HTX
- Cardiac surgery within the previous 3 months or planned at time of inclusion
- Acute coronary syndrome within the previous 3 months
- Chronic renal dialysis
- Pregnant or breast-feeding women
- Limited contractual capability
- Participation in another study
- Anticipated non-compliance with the follow-up scheme
- Life expectancy not longer than 1.5 years due to a non-cardiac disease
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
- 主な目的：支持療法
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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 |
|---|---|---|
|
HF Events
時間枠：21 months follow-up
|
Long-term impedance trends in patients with clinically relevant HF events, to support the development of impedance based detection algorithms.
A posterior assessment of sensitivity and false alarm rate of the detection algorithms.
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21 months follow-up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Shoda Morio, DR、Tokyo Women's University Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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