Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
2019年7月24日 更新者：Edwards Lifesciences
The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.
調査の概要
詳細な説明
This is a prospective, non-randomized, non-controlled observational clinical trial.
Up to 200 subjects will be enrolled at up to 6 participating clinical sites.
The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve.
Patients will be followed and assessed after implant for up to 5 years.
研究の種類
介入
入学 (実際)
133
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Kraków、ポーランド、31-202
- Krakowski Szpital Specjalistyczny im. Jana Pawła II
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Warsaw、ポーランド、04-628
- Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- 18 years or older
- Require replacement of aortic valve
- Signed informed consent
- Willing to return to study site for follow-up visits
Exclusion Criteria:
- Active endocarditis/myocarditis (< 3 months)
- Myocardial infarction (< 30 days)
- Renal insufficiency/ End-stage renal disease
- Life expectancy (< 1 year)
- Requires multiple valve replacement/repair
- Requiring emergent aortic valve surgery
- Pregnant or lactating
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 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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実験的：Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
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Implant of an aortic valve, Model 11000
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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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早期有害事象数を被験者数で割ったもの（パーセントで表示）
時間枠：手続きから30日以内に発生したイベント
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手順の 30 日以内に発生した初期の有害事象の数を、登録された被験者の数で割って 100 倍した値
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手続きから30日以内に発生したイベント
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Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
時間枠：Events occurring >= 31 days and up through 5 years post-implant
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Number of late events divided by the total number of late patient years x 100.
Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).
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Events occurring >= 31 days and up through 5 years post-implant
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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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Subject's Average Mean Gradient Measurements
時間枠：Baseline through 5-Year (at each scheduled follow-up visit)
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Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Gradients are evaluated by echocardiography over time.
Mean gradient values depend on the size and type of valve.
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Baseline through 5-Year (at each scheduled follow-up visit)
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Subject's Average Effective Orifice Area Measurements
時間枠：Baseline through 5-Year (at each scheduled follow-up visit)
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Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve.
Effective orifice area is evaluated by echocardiography over time.
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Baseline through 5-Year (at each scheduled follow-up visit)
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Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
時間枠：3-6 Months and 1 through 5 Years compared to baseline
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The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. |
3-6 Months and 1 through 5 Years compared to baseline
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Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
時間枠：Baseline and one year follow-up
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The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status. |
Baseline and one year follow-up
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Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
時間枠：Baseline and 1 Year
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The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000.
A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.
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Baseline and 1 Year
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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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Subject's Average White Blood Cell Count
時間枠：Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Red Blood Cells Count
時間枠：Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Hemoglobin Count
時間枠：Baseline, 3-6 months, and 1 through 5 years
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Laboratory Analysis of Hemoglobin Count on blood drawn from subjects.
Hemoglobin is an oxygen-carrying protein in red blood cells.
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Baseline, 3-6 months, and 1 through 5 years
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Subject's Average Hematocrit Percentage
時間枠：Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects.
Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Platelet Count
時間枠：Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Plasma Free Hemoglobin
時間枠：Baseline, 3-6 Months, and 1 through 5 Years
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Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects.
This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).
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Baseline, 3-6 Months, and 1 through 5 Years
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Subject's Average Serum Creatinine
時間枠：Baseline
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Laboratory Analysis of Serum Creatinine on blood drawn from subjects.
Creatinine blood test is a test that measures kidney function.
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Baseline
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Subject's Average International Normalized Ratio
時間枠：Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects. The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot. |
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Subject's Average Partial Thromboplastin Time
時間枠：Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects.
PTT is a blood test that looks at how long it takes for the blood to clot.
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Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Subject's Average Prothrombin Time
時間枠：Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects.
The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.
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Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jerzy Sadowski, MD、John Paul II Hospital
- 主任研究者：Jacek Rozanski, MD、The Cardinal Stefan Wyszynski Institute of Cardiology
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
- Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
- Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
- Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年7月1日
一次修了 (実際)
2018年7月1日
研究の完了 (実際)
2018年7月1日
試験登録日
最初に提出
2012年7月18日
QC基準を満たした最初の提出物
2012年7月24日
最初の投稿 (見積もり)
2012年7月26日
学習記録の更新
投稿された最後の更新 (実際)
2019年7月26日
QC基準を満たした最後の更新が送信されました
2019年7月24日
最終確認日
2019年7月1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。