Association Between Changes in Aortic Valve Area and Pulmonary Congestion After Transcatheter Aortic Valve Implantation
Association Between Changes in Aortic Valve Area and Pulmonary Congestion in Patients Undergoing Transcatheter Aortic Valve Implantation
調査の概要
詳細な説明
Patients with severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI will be prospectively enrolled in this single-center observational cohort study. A total of 52 patients are planned to be included.
Pulmonary congestion will be assessed using standardized lung ultrasound examinations performed at predefined time points during the peri-procedural period. Lung ultrasound assessment will primarily quantify B-lines and will also document relevant findings such as pleural effusion and consolidation. Assessments will be performed before TAVI and repeated after the procedure to characterize temporal changes in pulmonary congestion.
Aortic valve hemodynamics, including aortic valve area, will be assessed by transthoracic echocardiography. The principal analysis will evaluate the relationship between the change in aortic valve area after TAVI and the corresponding change in lung ultrasound findings. In particular, the association between the change in aortic valve area and the change in lung ultrasound findings at 24 hours will be evaluated.
By integrating echocardiographic assessment of valve hemodynamics with serial lung ultrasound, the study aims to characterize the relationship between hemodynamic improvement following TAVI and early changes in pulmonary congestion.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Metin İlteray Kıkılı, MD
- 電話番号：+905439782131
- メール：metin.kikili@iuc.edu.tr
研究場所
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Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34098
- 募集
- Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
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コンタクト：
- Metin İlteray Kıkılı, MD
- 電話番号：+905439782131
- メール：metin.kikili@iuc.edu.tr
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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:
- Age ≥18 years
- Diagnosis of severe symptomatic aortic stenosis
- Scheduled for elective transfemoral transcatheter aortic valve implantation (TAVI)
- Availability of preprocedural transthoracic echocardiography
- Feasibility of lung ultrasound examination
- Provision of written informed consent
Exclusion Criteria:
- Active pneumonia
- Interstitial lung disease or pulmonary fibrosis
- Massive pleural effusion
- Acute decompensated heart failure
- Severe exacerbation of chronic obstructive pulmonary disease (COPD)
- Conditions precluding adequate thoracic ultrasound examination
- Severe mitral stenosis
- Clinically significant severe mitral regurgitation
- Development of a major complication during the procedure
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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TAVI Cohort
Patients with severe symptomatic aortic stenosis undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) as part of routine clinical care.
Lung ultrasound and echocardiographic assessments will be performed at predefined time points to evaluate changes in pulmonary congestion and aortic valve hemodynamics.
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Transfemoral transcatheter aortic valve implantation (TAVI) performed as part of routine clinical care in patients with severe symptomatic aortic stenosis.
The decision to perform TAVI and procedural management are independent of study participation.
No modification of the TAVI procedure is made for research purposes.
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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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Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
時間枠：From preprocedural baseline to 24 hours after TAVI
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The primary outcome is the correlation between the change in aortic valve area (AVA), measured by transthoracic echocardiography and expressed in cm², and the change in total lung ultrasound (LUS) score after TAVI.
Lung ultrasound will be performed at three time points: immediately before anesthesia (T1), immediately after TAVI (T2), and 24 hours after the procedure (T3).
Both hemithoraces will be examined in 12 thoracic zones.
Each zone will be scored from 0 to 3 according to the degree of loss of aeration: 0 = normal aeration, characterized by A-lines or fewer than 2 B-lines with lung sliding; 1 = mild alveolar-interstitial pattern, characterized by 3 or more well-spaced B-lines with lung sliding; 2 = severe alveolar-interstitial pattern, characterized by multiple crowded and coalescent B-lines occupying >50% of the scanned intercostal space with lung sliding; and 3 = severe loss of aeration, characterized by a tissue-like pattern or consolidation.
The scores from all 12 zones will
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From preprocedural baseline to 24 hours after TAVI
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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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Change in B-Line Count After TAVI
時間枠：From preprocedural baseline to 24 hours after TAVI
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Change in the total number of B-lines assessed by lung ultrasound from the preprocedural baseline to 24 hours after transcatheter aortic valve implantation (TAVI).
B-lines will be assessed in predefined thoracic zones, and the change in B-line count following TAVI will be evaluated as a marker of change in pulmonary congestion.
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From preprocedural baseline to 24 hours after TAVI
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協力者と研究者
捜査官
- 主任研究者：Metin İlteray Kıkılı, MD、Istanbul University - Cerrahpasa
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
- Ay099DWe
個々の参加者データ (IPD) の計画
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