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Transventricular Off-pump Mitral Valve Repair (TRANSOM)

2026年7月20日 更新者：Johns Hopkins University

Transventricular Off-pump Mitral Valve Repair (TRANSOM)

The purpose of this study is to assess the safety and effectiveness (usefulness) of an investigational technique used to repair the mitral valve for patients with mitral regurgitation due to a defective valve leaflet. This procedure is called trans-ventricular off-pump mitral valve repair (TRANSOM) and it repairs the mitral valve by replacing some of the cords that support the mitral valve. This type of repair is minimally-invasive since it is performed through a small incision and avoids making a breast-bone-splitting incision.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

The key advantages of TRANSOM are that it is less invasive, requiring a small non-rib-spreading chest incision rather than a sternotomy, which splits the breastbone.

研究の種類

介入

入学 (推定)

175

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。

研究連絡先

研究連絡先のバックアップ

  • 名前：Rachael Quinn, PhD
  • 電話番号：410.955.2800
  • メール：rquinn17@jhmi.edu

研究場所

  • アメリカ
    • Maryland
      • Baltimore、Maryland、アメリカ、21287
        • 募集
        • Johns Hopkins Hospital
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • James S. Gammie, MD

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

説明

Inclusion Criteria:

  • Age 21 years or older.
  • Presence of severe degenerative mitral regurgitation confirmed by echocardiography.
  • Mitral leaflet anatomy suitable for coaptation to allow reduction of mitral regurgitation without undue leaflet tension.
  • Ability to provide informed consent and willingness to comply with study procedures and follow-up.

Exclusion Criteria:

  • Functional mitral regurgitation.
  • Severe mitral annular or leaflet calcification.
  • Significant concomitant valvular disease (e.g., severe aortic stenosis or insufficiency, severe tricuspid regurgitation).
  • Left ventricular ejection fraction <30% or severe right ventricular dysfunction.
  • Requirement for concomitant cardiac surgery.
  • Prior cardiac valve intervention or structural heart procedure (excluding prior PCI).
  • Recent major cardiovascular events (e.g., stroke or myocardial infarction within 30 days).
  • Hemodynamic instability or cardiogenic shock at the time of enrollment.
  • Significant comorbid conditions that increase procedural risk, including advanced liver disease, severe hematologic abnormalities, or active infection.
  • Contraindications to study procedures or required medications, including inability to tolerate anticoagulation or transesophageal echocardiography.
  • Pregnancy, lactation, or planned pregnancy during the study period.
  • Participation in another investigational device or drug study that could interfere with outcomes.
  • Life expectancy less than 12 months or any condition that, in the opinion of the investigator, precludes study participation.

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
実験的：Transventricular off-pump mitral valve repair
Participants with severe degenerative mitral regurgitation will undergo transventricular off-pump mitral valve repair for the treatment of degenerative mitral regurgitation.
デバイス：TRANSOM
TRANSOM is a minimally-invasive treatment that involves making a small incision between the ribs of the left chest, inserting a thin tube directly into the heart while it is beating, and placing the suture material onto the edges of the valve flaps so that the valves come together properly.

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
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
時間枠：30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
Freedom from a composite of major adverse events including all-cause mortality, all stroke, acute kidney injury (AKI), major bleeding, new permanent pacemaker implantation, deep sternal wound infection (DSWI) or access site infection requiring surgical intervention, and prolonged mechanical ventilation.
30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
時間枠：1 year post-index procedure.
Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
1 year post-index procedure.

二次結果の測定

結果測定
メジャーの説明
時間枠
Technical Success
時間枠：Exit from operating room and up to 30 days post-procedure.
Technical success is defined as patient survival to exit from the operating room, successful implantation of at least three ePTFE cords, and absence of procedure-related emergency surgery or reintervention.
Exit from operating room and up to 30 days post-procedure.
Procedural Success
時間枠：Exit from operating room and up to 30 days post-procedure.
Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
Exit from operating room and up to 30 days post-procedure.
Patient Success
時間枠：1 year post-index procedure.
Defined as procedural success with patient return to the pre-procedural living setting, absence of rehospitalization or reintervention for mitral regurgitation, and appropriate improvement or stability in New York Heart Association (NYHA) functional class.
1 year post-index procedure.
Blood Product Usage
時間枠：Perioperative through hospital discharge (an average of 4 days following the index procedure).
Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
Perioperative through hospital discharge (an average of 4 days following the index procedure).
Procedure Time
時間枠：During the index procedure.
Time from first incision to incision closure (hours).
During the index procedure.
Operating Room Time
時間枠：During the index procedure.
Time from entry into the operating room suite until exit from the operating room suite (hours).
During the index procedure.
Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
時間枠：During the index procedure.
Percentage of subjects receiving mitral valve replacement during the index procedure.
During the index procedure.
Composite Effectiveness Endpoint
時間枠：1 year post-index procedure.
Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.
1 year post-index procedure.
Discharged to Home vs Other Facility
時間枠：At hospital discharge (an average of 4 days following the index procedure).
Discharge disposition following hospitalization, including discharge to home versus another facility.
At hospital discharge (an average of 4 days following the index procedure).
New York Heart Association (NYHA) Functional Class
時間枠：Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
New York Heart Association functional class (Class I-IV), where Class I indicates no limitation of physical activity and Class IV indicates symptoms at rest; higher class indicates worse functional status.
Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
Mitral Regurgitation Grade
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram.
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Diastolic Diameter (LVEDD)
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Systolic Diameter (LVESD)
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Diastolic Volume (LVEDV)
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mL).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular End Systolic Volume (LVESV)
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mL).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Ventricular Ejection Fraction (LVEF)
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (%).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Left Atrial Volume
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mL).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Mitral Annular Septal-Lateral Dimension
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Right Ventricular Systolic Pressure (RVSP)
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mmHg).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Mitral Valve Peak Gradient
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mmHg).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Mitral Valve Mean Gradient
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram (mmHg).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Tricuspid Valve Regurgitation (TVR) Grade
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram.
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Right Ventricular Function
時間枠：Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Measured by transthoracic echocardiogram using tricuspid annular plane systolic excursion (TAPSE) and global assessment of right ventricular function (normal, mild dysfunction, moderate dysfunction, or severe dysfunction).
Baseline and at 7 days post-procedure or hospital discharge (whichever occurs first), 30 days, and 12, 24, 36, 48, and 60 months post-procedure.
Ventilation Duration
時間枠：At extubation (an average of 2 hours following the index procedure).
Total ventilation duration following the index procedure (hours).
At extubation (an average of 2 hours following the index procedure).
Intensive Care Unit Length of Stay
時間枠：At ICU discharge (an average of 1 day following the index procedure).
Total intensive care unit length of stay following the index procedure (hours).
At ICU discharge (an average of 1 day following the index procedure).
Hospital Length of Stay
時間枠：At hospital discharge (an average of 4 days following the index procedure).
Total hospital length of stay following the index procedure (days).
At hospital discharge (an average of 4 days following the index procedure).

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

Johns Hopkins University

捜査官

  • 主任研究者：James Gammie, MD、Johns Hopkins University

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8日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2029年7月1日

試験登録日

最初に提出

2026年7月6日

QC基準を満たした最初の提出物

2026年7月20日

最初の投稿 (実際)

2026年7月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月24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20日

最終確認日

2026年7月1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

  • IRB00416988

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