Left Atrial Appendage Occlusion Study II (LAAOSII)
Phase III Pilot Study - Left Atrial Appendage Occlusion Study
A pilot, multicentre randomized controlled study of surgical left atrial occlusion (LAA) in 50 patients with atrial fibrillation/flutter undergoing cardiac surgery requiring cardiopulmonary bypass with additional risk factors for late stroke.
Patients will be enrolled and randomized to undergo LAA exclusion and aspirin therapy or best medical therapy as per guidelines.
Main research questions:
- Can successful occlusion of the LAA be safely achieved by cut and sew or stapler techniques?
- In patients with atrial fibrillation with 2 or more risk factors for stroke, will removal of the left atrial appendage (LAA) and aspirin therapy reduce the risk of systemic embolic events and major bleeding compared to warfarin?
調査の概要
詳細な説明
The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events.
LAAOS pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. From this study we envision a a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ontario
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Hamilton、Ontario、カナダ、L8L 2X2
- Hamilton General 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:
- Adult patients undergoing any cardiac surgical procedure with the use of cardiopulmonary bypass
A history of ECG-documented atrial fibrillation with prior stroke or TIA, or at least two of the following risk factors:
- age => 65 years
- hypertension
- diabetes mellitus, or
- heart failure/left ventricular ejection fraction < 50%
Exclusion Criteria:
- Patients in whom surgical AF ablation (MAZE or otherwise) is planned
- Planned "off-pump" surgery
- Planned implantation of a mechanical valve
- Heart transplant, complex congenital heart surgery, and ventricular assist device insertion, reoperation
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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：Occlusion arm
Surgical intervention: Occlusion of the left atrial appendage (LAA) using 'cut-and-sew' technique appendage occlusion.
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Study intervention: Within the trial, occlusion must be performed using either amputation and closure (cut and sew) or stapler device.
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アクティブコンパレータ：Medical arm
Medical arm: The comparator is best medical practice for atrial fibrillation related stroke prevention as per guidelines.
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Best medical practice for atrial fibrillation related stroke prevention as per guidelines.
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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 |
時間枠 |
|---|---|
|
Demonstration of efficacy of cut-and-sew and stapler technique of appendage occlusion by intraoperative transesophageal echocardiography, central adjudication.
時間枠：Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Demonstration of study feasibility, procedure safety, including rate of post-operative re-exploration for bleeding.
時間枠：Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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Outcomes will be measured at discharge, 4-8 weeks post-op and long term (1 to 4 years)
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協力者と研究者
協力者
捜査官
- 主任研究者：Richard Whitlock, MD, FRCSC、McMaster University
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
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。