AMPLATZER Cardiac Plug Clinical Trial
Amplatzer Cardiac Plug Clinical Trial
調査の概要
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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California
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Los Angeles、California、アメリカ、90048
- Cedars-Sinai Medical Center
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Los Angeles、California、アメリカ、90017
- Good Samaritan Hospital
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado Denver
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Littleton、Colorado、アメリカ、80120
- South Denver Cardiology Associates
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory Midtown Hospital and Emory University Hospital
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Atlanta、Georgia、アメリカ
- St. Joseph's Hospital and Research Institute
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Iowa
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Iowa City、Iowa、アメリカ、52242
- University of Iowa Hospitals & Clinics
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Kentucky
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Lexington、Kentucky、アメリカ、40506
- University of Kentucky
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Michigan
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Detroit、Michigan、アメリカ、48202
- Henry Ford Hospital
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Grand Rapids、Michigan、アメリカ、49503
- Spectrum Health
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Southfield、Michigan、アメリカ、48075
- Providence Hospital
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Minnesota
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Saint Cloud、Minnesota、アメリカ、56303
- St. Cloud Hospital/CentraCare Heart and Vascular Clinic
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Saint Paul、Minnesota、アメリカ、55102
- HealthEast St. Joseph's Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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York、Pennsylvania、アメリカ、17405
- York Hospital
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South Carolina
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Charleston、South Carolina、アメリカ、29401
- Roper Hospital/PMG Research of Charleston
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Texas
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Houston、Texas、アメリカ、77030
- Memorial Hermann Hospital
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Wisconsin
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Wausau、Wisconsin、アメリカ、54401
- Aspirus Heart & Vascular Institute
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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 have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
- Subject must be ≥18 years of age
- Subject must be on warfarin or dabigatran therapy
- Subject must be eligible for long term warfarin or dabigatran therapy
- Subject must have a CHADS(2) score of 2 or greater
Summary of Exclusion Criteria:
- Subject who requires warfarin or dabigatran for a condition other than AF
- Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
- Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
- Subject with a New York Heart Association (NYHA) classification equal to IV
- Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
- Subject with aortic or mitral valve regurgitation of grade 2+ or greater
- Subject with left ventricular ejection fraction (LVEF) ≤30
- Subject with mitral or aortic prosthetic valve
- Subject with a history of hemorrhagic or aneurysmal stroke
- Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
- Subject with a body mass index (BMI) ≥40
- Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
- Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment
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：Device
AMPLATZER Cardiac Plug
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AMPLATZER Cardiac Plug is a percutaneous transcatheter device
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アクティブコンパレータ：Optimal Medical Therapy (control)
Warfarin Dabigatran
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AMPLATZER Cardiac Plug is a percutaneous transcatheter device
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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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Acute Safety - Procedure Related SAEs From Randomization Through Discharge For Device Arm Only
時間枠：From Randomization to Discharge Visit
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An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm below. The secondary endpoint analysis requirement was removed from the protocol. |
From Randomization to Discharge Visit
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Long-term Safety - Device Arm Only
時間枠：Randomization to 2 year follow-up
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All-Cause Mortality and Major Bleeds Through 2 years in device arm subjects only. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. |
Randomization to 2 year follow-up
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Effectiveness Endpoint - Device Arm Only
時間枠：Randomization through 2 year follow up
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Occurrence of ischemic stroke and peripheral thromboembolism in the device arm. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Control arm subjects exited the study early, no sufficient data was available to summarize any endpoints. The three primary endpoints as mentioned in the Appendix D of the clinical investigational plan (Revision 06, dated September 2014) were summarized for the Device arm. The secondary endpoint analysis requirement was removed from the protocol. |
Randomization through 2 year follow up
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協力者と研究者
スポンサー
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 (実際)
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。
AMPLATZER Cardiac Plugの臨床試験
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