KONECT RESILIA Aortic Valved Conduit (AVC) Real-world Study Assessing Safety and Performance (KONECTION)
2026年7月16日 更新者：Edwards Lifesciences
KONECTION is a prospective, observational, single-arm, multicenter study designed to collect real-world clinical outcomes in up to 250 participants who will receive the KONECT RESILIA aortic valved conduit, Model 11060A.
調査の概要
詳細な説明
Subjects in the KONECTION study will be enrolled at up to 20 sites in Europe and Canada.
The population will be participants requiring replacement of their diseased native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.
研究の種類
観察的
入学 (推定)
250
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。
研究連絡先
- 名前：Sabrina Hundt, PhD
- 電話番号：+49 (0)151 67550601
- メール：Sabrina_Hundt@edwards.com
研究場所
-
-
Bavaria
-
München、Bavaria、ドイツ、80636
- 募集
- TUM Klinikum Deutsches Herzzentrum
-
主任研究者：
- Markus Krane, Prof. Dr. med.
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
The target population includes adult candidates who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.
説明
Inclusion Criteria:
- 18 years or older at the time of informed consent
- Have a diseased native or prosthetic aortic valve and a damaged or diseased ascending aorta that requires aortic valved conduit replacement surgery with the KONECT RESILIA AVC
- Provide written informed consent
- Willing to follow protocol requirements
Exclusion Criteria:
- Active endocarditis or endocarditis within 3 months prior to the study index procedure
- Emergency procedure
- Stage 4 renal disease (estimated glomerular filtration rate [eGFR] <30 excluded) or requiring dialysis
- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease in the opinion of the study investigator
- High predicted risk of mortality prior to the procedure: Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM) ≥8%
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Edwards KONECT RESILIA AVC
Subjects who were treated with the Edwards KONECT RESILIA AVC
|
Surgical replacement of the aortic valve and ascending aorta with the Edwards KONECT RESILIA AVC
|
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 |
|---|---|---|
|
Percentage of participant's freedom from death and/or device related reintervention
時間枠：≤ 30 days
|
Participants' freedom from valve-related death or valve- and/or graft-related reintervention.
Time to events were estimated by Kaplan-Meier method.
|
≤ 30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Participant's linearized rate of thromboembolism
時間枠：Events occurring ≥ 31 days and up through 5 years post-implant
|
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100].
Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact.
Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
|
Events occurring ≥ 31 days and up through 5 years post-implant
|
|
Participant's linearized rate of valve thrombosis
時間枠：Events occurring ≥ 31 days and up through 5 years post-implant
|
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100].
Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact.
Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
|
Events occurring ≥ 31 days and up through 5 years post-implant
|
|
Participant's linearized rate of major paravalvular leak
時間枠：Events occurring ≥ 31 days and up through 5 years post-implant
|
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100].
Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact.
Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
|
Events occurring ≥ 31 days and up through 5 years post-implant
|
|
Participant's linearized rate of endocarditis
時間枠：Events occurring ≥ 31 days and up through 5 years post-implant
|
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100].
Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact.
Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
|
Events occurring ≥ 31 days and up through 5 years post-implant
|
|
Participant's linearized rate of major hemorrhage
時間枠：Events occurring ≥ 31 days and up through 5 years post-implant
|
A linearized rate percentage is calculated by the following equation: [(Total number of late adverse events in each category/total number of late patient years) x 100].
Late adverse events are events that occur ≥ 31 days post-implant through each subject's last follow-up visit or contact.
Late patient years are calculated by totaling the amount of time the valve is implanted in the patient while participating in the trial and the count begins at ≥ 31 days post-implant through all subject's last follow-up visit or contact.
|
Events occurring ≥ 31 days and up through 5 years post-implant
|
|
Percentage of participant's with freedom from death and/or device related reintervention
時間枠：1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
|
Participants' freedom from valve-related death or valve- and/or graft-related reintervention.
Time to events were estimated by Kaplan-Meier method.
|
1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
|
|
Participant's functional improvement over time from baseline for New York Heart Association (NYHA) Class
時間枠：Baseline, 1 month, 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
|
The New York Heart Association 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 anginal syndrome may be present even at rest. |
Baseline, 1 month, 1-, 2-, 3-, 4-, 5-, 6-, 7-, 8-, 9-, and 10- Years follow-up
|
|
Participant's average mean gradient measurement over time
時間枠：1 month, 1-, 3-, and 5- Years follow-up
|
Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury.
Gradients are evaluated by echocardiography over time.
In general, a higher value is considered worse, and a lower value is considered better but the value is dependent on the size and type of valve.
|
1 month, 1-, 3-, and 5- Years follow-up
|
|
Participant's average peak gradient measurement over time
時間枠：1 month, 1-, 3-, and 5- Years follow-up
|
Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury.
Gradients are evaluated by echocardiography over time.
In general, a higher valve is considered worse, and a lower value is considered better, but the value is dependent on the size and type of valve.
|
1 month, 1-, 3-, and 5- Years follow-up
|
|
Participant's average Effective Orifice Area (EOA) measurement over time
時間枠：1 month, 1-, 3-, and 5- Years follow-up
|
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.
In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size and type of valve.
|
1 month, 1-, 3-, and 5- Years follow-up
|
|
Participant's average Effective Orifice Area Index (EOAI) measurement over time
時間枠：1 month, 1-, 3-, and 5- Years follow-up
|
Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area.
Effective orifice area index is evaluated by echocardiography over time.
In general, a higher value is considered better, and a lower value is considered worse, but the value is dependent on the size of the patient and the size and type of valve.
|
1 month, 1-, 3-, and 5- Years follow-up
|
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：Markus Krane, Prof. Dr. med.、TUM Universitätsklinikum Deutsches Herzzentrum
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 (実際)
2026年6月25日
一次修了 (推定)
2028年12月31日
研究の完了 (推定)
2039年6月30日
試験登録日
最初に提出
2026年5月26日
QC基準を満たした最初の提出物
2026年5月26日
最初の投稿 (実際)
2026年6月2日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月17日
QC基準を満たした最後の更新が送信されました
2026年7月16日
最終確認日
2026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。