CHATEAU Registry: Clinical Outcomes After Transcatheter Aortic Valve Replacement (CHATEAU)
Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: The Collaborative Hexagon-Asian Transcatheter Aortic Valve Replacement Union (CHATEAU) Registry
調査の概要
詳細な説明
The CHATEAU Registry is an international, multicenter, observational registry of patients undergoing transcatheter aortic valve replacement. This study will retrospectively analyze consecutive 4,000 patients treated with TAVR at participating centers from January 1, 2021 to December 31, 2025. Follow-up clinical outcomes will be assessed through December 31, 2027.
Eligible patients are adults who underwent TAVR for aortic valve disease. Data will be collected from existing medical records, including baseline demographics, comorbidities, laboratory findings, pre-procedural imaging data, procedural details, device information, post-procedural echocardiographic findings, discharge medications, and clinical follow-up outcomes.
The study aims to evaluate the association between patient-, anatomy-, device-, and procedure-related factors and subsequent clinical outcomes and valve performance. Outcomes of interest may include all-cause death, cardiovascular death, stroke, myocardial infarction, heart failure hospitalization, pacemaker implantation, valve hemodynamic deterioration, aortic valve reintervention, paravalvular regurgitation, and other TAVR-related clinical events.
Because this is a retrospective observational study, all treatment decisions were made according to routine clinical practice at each participating institution. The study does not involve randomization, assignment of treatment, additional procedures, or additional patient visits. All data will be handled in accordance with applicable institutional review board requirements and privacy regulations.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Osung Kwon, MD. PhD
- 電話番号：+821037085673
- メール：oscaesar@gmail.com
研究場所
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Seoul、韓国、03312
- 募集
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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コンタクト：
- Osung Kwon, MD, PhD
- 電話番号：+821037085673
- メール：oscaesar@gmail.com
-
コンタクト：
-
主任研究者：
- Osung Kwon, MD, PhD
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参加基準
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adults (≥18 years of age).
- Patients who underwent transcatheter aortic valve replacement (TAVR) for severe native aortic valve disease at participating centers.
- TAVR performed between January 1, 2021 and December 31, 2025.
- Availability of baseline procedural and follow-up clinical data in the institutional registry or medical records.
Exclusion Criteria:
- Patients with insufficient clinical or procedural data for outcome assessment.
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 |
|---|---|
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CHATEAU Registry Cohort
Consecutive adult patients with severe aortic valve disease who underwent transcatheter aortic valve replacement (TAVR) between January 1, 2021 and December 31, 2025 at participating centers in the CHATEAU Registry.
Clinical, imaging, procedural, and follow-up data are collected retrospectively from routine clinical practice.
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Transcatheter aortic valve replacement (TAVR) performed according to routine clinical practice using commercially available transcatheter heart valves and standard procedural techniques at participating centers.
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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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All-Cause Mortality
時間枠：From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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Death from any cause occurring after transcatheter aortic valve replacement (TAVR) during follow-up.
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From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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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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Cardiovascular Mortality Stroke Heart Failure Hospitalization Myocardial Infarction Aortic Valve Reintervention Valve Hemodynamic Deterioration Prosthetic Valve Endocarditis/thrombosis Permanent pace maker insertion Major Bleeding
時間枠：From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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Outcome events will be assessed during follow-up using routinely collected clinical and imaging data.
Clinical events will be defined according to the Valve Academic Research Consortium-3 (VARC-3) criteria, where applicable, and adjudicated according to each participating center's standard clinical practice.
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From the index TAVR procedure through December 31, 2027 (up to approximately 6 years)
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協力者と研究者
捜査官
- 主任研究者：Osung Kwon, MD, PhD、The Catholic University of Korea Eunpyeong St. Mary's Hospital
研究記録日
主要日程の研究
研究開始 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- CHATEAU-REG-001
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
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