Acute Defibrillation Study
調査の概要
詳細な説明
The study recruited male and female subjects that met all of the inclusion criteria and none of the exclusion criteria. All subjects were scheduled to undergo surgical procedures outlined in the inclusion criteria. These surgical procedures were chosen as the patient population for this study because these procedures require similar personnel and may require access to similar or the same spaces as the ASD procedure.
The entire ASD study research system was removed prior to proceeding with the subject's planned surgery per standard medical practice, which then proceeded according to the standard of care.
Subjects were followed through their routine post-surgery follow-up visit.
At the time of completing the follow-up visit, the subjects' participation was complete and the subjects exited the study.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Liverpool、イギリス、L14 3PE
- Liverpool Heart and Chest Hospital
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London、イギリス、SE5 9RS
- King's College Hospital
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Southampton、イギリス、SO16 6YD
- Southampton General Hospital
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Amsterdam、オランダ
- Academisch Medisch Centrum
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Nieuwegein、オランダ
- St. Antonius Ziekenhuis
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Krakow、ポーランド、31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawla II
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New Territories
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Sha Tin、New Territories、香港
- Prince of Wales 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:
- Subject must be undergoing surgical procedure for approved indications for
- cardiothoracic surgery where a midline sternotomy is planned, or
- implant of a transvenous (TV) ICD or subcutaneous ICD (S-ICD®), or
- VT ablation procedure, or
- VT inducibility testing during Electrophysiology (EP) study
- Subject must be willing to provide Informed Consent
- Subject must be ≥ 18 years old
Exclusion Criteria:
- Subject is considered to be at high risk for infection
- Subject has Left Ventricular Ejection Fraction (LVEF) ≤ 20%
- Subject at high risk of stroke
- Subject with an implanted active cardiac or non-cardiac device during study procedure (e.g., ICD, S-ICD®, Pacemaker, Neuro stimulator)
- Subject is pacemaker dependent
- Subject had previous pericarditis or prior sternotomy
- Subject has hiatus hernia or moderate or worse pectus excavatum
- Subject has hypertrophic cardiomyopathy
- Subject has severe aortic stenosis
- Subject has severe proximal three vessel coronary disease (over 70% in each vessel)
- Subject has >50% left main stem (LMS) disease
- Subject has known skin irritations to the Physio Control Fast Patch ECG Electrode
- Subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a Medtronic study manager
- Subject has medical conditions that would limit study participation
- Subject is pregnant
- Subject meets exclusion criteria required by local law (e.g. age, breast feeding, etc.)
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：処理
- 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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：VT/VF induction and defibrillation
Ventricular Tachycardia and Ventricular Fibrillation (VT/VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.
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Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.
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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 |
|---|---|---|
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Defibrillation Outcome
時間枠：Day of procedure
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Subjects will demonstrate a successful defibrillation outcome if they have a successful defibrillation shock with the research system.
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Day of procedure
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協力者と研究者
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 (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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。