Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery
調査の概要
詳細な説明
Primary Purpose To demonstrate the performance of the Bıçakcılar Aortic Root Cannula in patients for whom its use is planned, in accordance with the device's intended purpose as outlined in the user manual, taking into account the following aspects: bleeding, trauma, manipulation, placement and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its shape Secondary Objectives
- To obtain observational data on secondary evaluation parameters (demographic data, concomitant diseases and treatments, biochemistry and echocardiography findings, vital and cardiological assessments, perfusion and cardioplegia assessments)
- To evaluate the impact of the use of the Bıçakcılar Aortic Root Cannula on the development of adverse events and complications
- To conduct post-market clinical follow-up of the Bıçakcılar Aortic Root Cannula
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Gizem Özdemir, Biomedical Engineer
- 電話番号：+90 5346137760
- メール：gizemozdemir@kocyasa.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
The aim of this study is not to prove a hypothesis defined by a specific objective-numerical expectation, but rather to compile the various outcomes resulting from the use of a medical device, using data obtained from all cases collected within a timeframe deemed clinically appropriate and sufficient. In this context, a minimum sample size is determined without considering an objective expectation or the Type I and Type II statistical errors accepted in the research.
The sample will be formed by including participants such that even for the option with the fewest patients operated on-among the four options comprising two operative procedures and two cannula types-there will be at least 5 cases. Since the selection of the appropriate cannula is determined by the surgeon based on the patient's condition and characteristics, this sample will, to some extent, attempt to reflect real-world data on cannula use on a small scale.
説明
Inclusion Criteria:
Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,
- Patients for whom the use of an aortic root cannula is planned during surgery
- Patients who, prior to surgery, have provided consent in the "Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes" section regarding the use of their data
Exclusion Criteria:
Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel)
- Patients with calcified aorta, aortic valve insufficiency, occluded coronary arteries, the presence of adventitia or plaques, fibrosis in the aortic wall, or low arterial pressure Patients who have difficulty understanding the study and complying with it
- Patients who may pose a conflict of interest (e.g., relatives of employees of sponsoring companies)
- Patients who have participated in any clinical trial within the past 30 days
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
1
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The Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting.
The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries.
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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 |
|---|---|---|
|
Presence of bleeding
時間枠：It will be measured during the surgery up to 6 hours.
|
Primary endpoints are structured to encompass all clinical use outcomes characterizing device performance.
Evaluation items directly related to the Bıçakcılar Vent Catheter will be measured using a Likert scale with values ranging from 1 to 5.
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It will be measured during the surgery up to 6 hours.
|
|
Impact of trauma
時間枠：It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
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Manipulation during placement
時間枠：It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
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Catheter removal
時間枠：It will be measured during the surgery up to 6 hours.
|
It will be used 5-likert scale.
|
It will be measured during the surgery up to 6 hours.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- CIP-33001
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。