"EASE" Epicardial Access With the EpiAccess System (EASE2)
EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
調査の概要
詳細な説明
Prior to enrolment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be enrolled in the study by the local principal investigator after informed consent is obtained.
As EpiAccess is only used for the access portion of electrophysiology procedures, the safety, performance and effectiveness endpoints are acute from the time of needle insertion to pericardial space access (guidewire insertion into the pericardial sac). Patients will be followed until hospital discharge. Follow-up clinical examinations will be performed in accordance with institutions' standard of care. No special tests are required for this device. Patients' completion of study will occur at the time of their hospital discharge, or earlier if patient did not complete the study.
The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as defined in this protocol, after enrolment of 10 or more patients, compared to existing data from the literature presenting epicardial access procedure results during sub-xyphoid (minimally invasive) surgical procedures.
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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-
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Prague、チェコ共和国
- Nemocnice Na Homolka
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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 is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
Exclusion Criteria:
- Patient with history of cardiac or pericardial surgery in the past 6 months
- Patient with history of chronic pericarditis
- Myocardial infarction within 4 weeks prior to procedure
- Class IV NYHA (New York Heart Association) heart failure symptoms
- Cerebrovascular accident within previous 6 months
- Known carotid artery stenosis greater than 80%
- Presence of thrombus in the left atrium
- Coagulopathy
- Severe Hepatic Dysfunction or Enlargement
- Life expectancy less than 6 months
- BMI > 40
- Patient is enrolled in another clinical trial
- Patient is pregnant
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）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：EpiAccess
EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.
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Access to the pericardium to enable further treatments.
他の名前：
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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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Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
時間枠：Through discharge / approx 4 days
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EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved.
The percentage of patients in whom pericardial access was successful will be reported.
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Through discharge / approx 4 days
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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 |
|---|---|---|
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Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
時間枠：access through procedure completion
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EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques.
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access through procedure completion
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Percentage of Participants With a Pericardial Effusion of >80ml
時間枠：Access through discharge/approximately 4 days
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Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.
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Access through discharge/approximately 4 days
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
時間枠：Access through end of procedure
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Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey
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Access through end of procedure
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Andrea Natale, MD、University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary
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
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。