Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation (MASTER-TAVI II)
2026年5月28日 更新者：Josep Rodes-Cabau
Evaluation of a Treatment Algorithm for the Management of TAVI Patients With Significant Concomitant Mitral or Tricuspid Regurgitation
Aortic stenosis is a condition in which the aortic valve becomes narrow and does not open properly, making it harder for the heart to pump blood to the body. Transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure commonly used to treat this condition, especially in older patients or patients at high surgical risk.
Many patients undergoing TAVI also have leakage of the mitral valve and/or tricuspid valve. These valve problems can cause symptoms such as shortness of breath, fatigue, swelling, heart failure, and repeated hospitalizations. Patients with multiple valve diseases generally have worse outcomes and are more difficult to treat.
In some patients, mitral or tricuspid valve leakage improves after TAVI because the heart works better once the aortic valve has been treated. However, in other patients, the leakage remains severe and continues to affect their health and quality of life. New minimally invasive treatments are now available to repair or replace the mitral and tricuspid valves, but doctors still do not know the best order or timing for these procedures.
This study aims to evaluate a treatment algorithm for patients with severe aortic stenosis and significant mitral and/or tricuspid valve leakage. The proposed approach follows current clinical guidelines and uses a stepwise strategy. Patients will first undergo TAVI, followed by reassessment of the mitral and tricuspid valves. If important valve leakage persists after TAVI, additional minimally invasive procedures may be considered to treat the mitral or tricuspid valve.
The study will include patients with severe aortic stenosis and moderate-to-severe or severe mitral and/or tricuspid regurgitation. Researchers will collect information about patient symptoms, heart imaging results, procedures, hospitalizations, quality of life, and clinical outcomes during follow-up.
The main goal of the study is to evaluate whether this staged treatment approach is safe, feasible, and effective in improving patient outcomes. Researchers will also assess whether the strategy can reduce hospitalizations for heart failure and improve symptoms, daily functioning, and quality of life.
The results of this study may help doctors better manage patients with multiple valve diseases and provide a more personalized and structured treatment approach for this complex group of patients.
調査の概要
状態
まだ募集していません
研究の種類
観察的
入学 (推定)
300
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：Melanie Côté, MSc
- 電話番号：2646 4186568711
- メール：melanie.cote@criucpq.ulaval.ca
研究連絡先のバックアップ
- 名前：Josep Rodes Cabau, MD PhD
- 電話番号：5593 14186568711
- メール：josep.rodes@criucpq.ulaval.ca
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
非確率サンプル
調査対象母集団
The study population will consist of adult patients with severe symptomatic aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) who also present with significant concomitant mitral regurgitation and/or tricuspid regurgitation. The study will mainly include elderly patients and patients considered at intermediate, high, or prohibitive surgical risk for conventional open-heart surgery.
Eligible participants will have moderate-to-severe or severe mitral and/or tricuspid valve regurgitation identified by echocardiography before TAVI. Patients will be evaluated and treated according to a staged transcatheter treatment algorithm based on current clinical guidelines and the evolution of valve disease following TAVI.
説明
Inclusion Criteria:
- Age >18 years.
- Patients with severe AS undergoing transarterial TAVI.
- Concomitant significant MR and/or TR (≥3+).
Exclusion Criteria:
- Life expectancy <1 year due to noncardiac conditions.
- Any prior mitral or tricuspid valve surgery.
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Active endocarditis.
- Subjects in whom transesophageal echocardiography is contraindicated or high risk.
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 |
|---|
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Concomitant isolated MR - 3+ or 4
Patients with severe aortic stenosis (AS) and significant mitral regurgitation (MR) undergoing TAVI followed, if needed, by mitral intervention (M-TEER).
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Concomitant isolated TR - 3+ to 5
Patients with severe AS and significant tricuspid regurgitation (TR) undergoing TAVI followed, if needed, by tricuspid intervention (T-TEER).
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Concomitant MR and TR
Patients with severe AS, MR, and TR undergoing staged triple-valve transcatheter therapy.
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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 or re-hospitalization for worsening heart failure
時間枠：Minimum of 1 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at a minimum of 1 year following the TAVI procedure
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Minimum of 1 year
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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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All-cause mortality or re-hospitalization for worsening heart failure
時間枠：1 Year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 1-year follow-up.
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1 Year
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All-cause mortality or re-hospitalization for worsening heart failure
時間枠：2 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 2-year follow-up
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2 year
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All-cause mortality or re-hospitalization for worsening heart failure
時間枠：3 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 3-year follow-up.
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3 year
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All-cause mortality or re-hospitalization for worsening heart failure
時間枠：4 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 4-year follow-up.
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4 year
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All-cause mortality or re-hospitalization for worsening heart failure
時間枠：5 year
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Composite of all-cause mortality or re-hospitalization for worsening heart failure at 5-year follow-up.
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5 year
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All-cause mortality
時間枠：1 year
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All-cause mortality at 1 year
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1 year
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All-cause mortality
時間枠：2 year
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All-cause mortality at 2 year
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2 year
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All-cause mortality
時間枠：3 year
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All-cause mortality at 3 year
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3 year
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All-cause mortality
時間枠：4 year
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All-cause mortality at 4 year
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4 year
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All-cause mortality
時間枠：5 year
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All-cause mortality at 5 year
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5 year
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Heart failure re-hospitalization
時間枠：1 year
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Heart failure re-hospitalization at 1 year
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1 year
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Heart failure re-hospitalization
時間枠：2 year
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Heart failure re-hospitalization at 2 year
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2 year
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Heart failure re-hospitalization
時間枠：3 year
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Heart failure re-hospitalization at 3 year
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3 year
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Heart failure re-hospitalization
時間枠：4 year
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Heart failure re-hospitalization at 4 year
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4 year
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Heart failure re-hospitalization
時間枠：5 year
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Heart failure re-hospitalization at 5 year
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5 year
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Cardiovascular mortality
時間枠：1 year
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Cardiovascular mortality at 1 year
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1 year
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Cardiovascular mortality
時間枠：2 year
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Cardiovascular mortality at 2 year
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2 year
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Cardiovascular mortality
時間枠：3 year
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Cardiovascular mortality at 3 year
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3 year
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Cardiovascular mortality
時間枠：4 year
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Cardiovascular mortality at 4 year
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4 year
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Cardiovascular mortality
時間枠：5 year
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Cardiovascular mortality at 5 year
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5 year
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All-cause mortality or heart failure re-hospitalization
時間枠：1 year
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Evaluation of the composite outcome (all-cause mortality or heart failure re-hospitalization) at 1-year follow-up compared with a historical cohort.
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1 year
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MR severity
時間枠：1 year
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MR severity at 1 year
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1 year
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MR severity
時間枠：2 year
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MR severity at 2 year
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2 year
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MR severity
時間枠：3 year
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MR severity at 3 year
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3 year
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MR severity
時間枠：4 year
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MR severity at 4 year
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4 year
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MR severity
時間枠：5 year
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MR severity at 5 year
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5 year
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TR severity
時間枠：1 year
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TR severity at 1 year
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1 year
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TR severity
時間枠：2 year
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TR severity at 2 year
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2 year
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TR severity
時間枠：3 year
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TR severity at 3 year
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3 year
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TR severity
時間枠：4 year
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TR severity at 4 year
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4 year
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TR severity
時間枠：5 year
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TR severity at 5 year
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5 year
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LVEF
時間枠：1 year
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LVEF at 1 year
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1 year
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LVEF
時間枠：2 year
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LVEF at 2 year
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2 year
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LVEF
時間枠：3 year
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LVEF at 3 year
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3 year
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LVEF
時間枠：4 year
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LVEF at 4 year
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4 year
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LVEF
時間枠：5 year
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LVEF at 5 year
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5 year
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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：Josep Rodes Cabau, MD PhD、IUCPQ-UL
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。
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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 (推定)
2026年6月5日
一次修了 (推定)
2029年6月5日
研究の完了 (推定)
2034年6月5日
試験登録日
最初に提出
2026年5月28日
QC基準を満たした最初の提出物
2026年5月28日
最初の投稿 (実際)
2026年6月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月3日
QC基準を満たした最後の更新が送信されました
2026年5月28日
最終確認日
2026年5月1日
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- MASTER-TAVI II
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Individual participant data (IPD) will not be publicly shared due to patient confidentiality and privacy considerations, as well as institutional and ethical restrictions governing the use of clinical research data.
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