Performance of the CARDIOGARD Cannula (GECG)
A Study to Collect Additional Information Related to the Performance of the CARDIOGARD Cannula
This is a single center, prospective study:
The 'CardioGard Cannula' Gaseous emboli capture results - shows an improvement from the control group.
調査の概要
詳細な説明
Patients referred for CPB procedure will be offered to participate in the study. Patients will be asked to sign an informed consent form (ICF), prior to performing any study related procedures.
The point of enrollment is the time at which a patient signs and dates the ICF. Following enrollment, the patient will undergo screening evaluation (including Neurological assessment) to determine eligibility. Screening failures will be identified on a screening log. Patients who are found to meet all inclusion criteria and none of the exclusion criteria will compose the evaluable cohort of the study. Screening failure subjects will not be counted as part of the target patient sample size nor will they be included in the analysis.
Patients in the randomized phase will have surgery with the CardioGard Cannula or comparator cannulae and will remain blinded to their group assignment through the 30 days follow-up evaluation.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
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 indicated for first-time non-emergent procedure under cardiopulmonary bypass which is expected to last up to 6 hours.
- Patient undergoing an elective isolated coronary artery bypass surgery (CABG), or an elective isolated aortic/mitral valve replacement (AVR/MVR) or an elective combined aortic/mitral valve replacement (AVR/MVR) with coronary artery bypass surgery (CABG).
- The patient is >50 and <85 years of age.
- The patient's body weight is compatible with blood net flow of 4 - 5 [l/min].
- Patient with left ventricular ejection fraction >30% as assessed by either echocardiography, angiography or by radio nuclear assessment (MUGA)
- The patient is willing to participate as evidenced by signing the written informed consent.
- Male or non-pregnant female patient (Note: Females of child bearing potential must have a negative pregnancy test)
Exclusion Criteria:
- Patient with abnormal clotting mechanism: PT 60%, PTT>2 the normal.
- Patient with an aortic trauma.
- Patient contraindicated for open heart surgery under bypass machine.
- Patient undergoing a re-do procedure.
- Patient intended for an operation performed using minimally invasive surgical techniques (e.g., mini-sternotomy)
- Patient with pathologies which affect his/her neurological condition.
- Patient in whom emergency operation is required.
- Patient with a known allergy to Heparin
Patient with major co-morbid condition(s) that could limit the patient's ability to participate in the study, or impact the scientific integrity of the study, including but not limited to:
- previous stroke
- critical preoperative state
- poor ventricular function
- severe pulmonary hypertension [19]
- Atheroembolism
- history of cardiac failure [20]
- Current use of drugs that might result in high surgical risk or significant postoperative complication.
- Psychological instability, inappropriate attitude or motivation.
- Patients with life threatening debilitating disease other than cardiac.
- Subjects currently enrolled in another investigational device or drug trial that has not completed the primary end point or that clinically interferes with the current study endpoints.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：CardioGard group
Patients in whom the CardioGard Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in two points: 1. The aortic vent. 2. The suction cannula of the 'Cardiogard cannula'. |
CardioGard Cannula is a specially designed arterial (aortic) cannula for use in cardiac surgery for the purpose of removal of gaseous and solid embolic material emanating during the CPB procedure. The CardioGard cannula is a double lumen cannula where the primary lumen provides blood from the heart-lung machine similar to ordinary cannulas and the secondary lumen performs suction of blood and embolic matter away from the aortic arch and back to the cardiopulmonary bypass machine for filtration. |
|
アクティブコンパレータ：Control group
Patients in whom a 22Fr curved Cannula will be used, while In these patients there would be a measurement of the gaseous emboli in the aortic vent alone.
|
arterial cannula for use in cardiac surgery
|
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 |
|---|---|---|
|
The 'CardioGard Cannula' Gaseous emboli capturing ability
時間枠：36 months
|
The gaseous emboli capturing ability of the cardiogard cannula will be evaluated using a bubbles counter. .
|
36 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The amount of emboli particles which evacuated from the cardiopulmonarybypass machine by the CardioGard Cannula
時間枠：36 months
|
Using the suction feature, External filters will be analyzed in order to recover particulate matter.
|
36 months
|
|
The Neurological effect of reducing gaseous emboli from the heart during cardiac surgery.
時間枠：36 months
|
The ability of the Cardiogard cannula will be evaluated using Neurological questionnaires.
|
36 months
|
協力者と研究者
捜査官
- 主任研究者：Gil - Bolotin, Prof.、Head of the Cardiac Surgery Department, Rambam Health Care Campus
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
本研究に関する用語
キーワード
その他の研究ID番号
- CLNG100 Full Protocol
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。