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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
175
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lisa Fornaresio, PhD
- 电话号码：443.927.3984
- 邮箱：lisa.fornaresio@jhmi.edu
研究联系人备份
- 姓名：Rachael Quinn, PhD
- 电话号码：410.955.2800
- 邮箱：rquinn17@jhmi.edu
学习地点
-
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Maryland
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Baltimore、Maryland、美国、21287
- 招聘中
- Johns Hopkins Hospital
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接触：
- Lisa Fornaresio, PhD
- 电话号码：443-927-3984
- 邮箱：lisa.fornaresio@jhmi.edu
-
接触：
- Rachael Quinn, PhD
- 电话号码：410.955.2800
- 邮箱：rquinn17@jhmi.edu
-
首席研究员：
- James S. Gammie, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
大体时间：30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
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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.
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30 days post-index procedure, or at hospital discharge approximately 4 days post index procedure
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Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
大体时间：1 year post-index procedure.
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Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
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1 year post-index procedure.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Technical Success
大体时间：Exit from operating room and up to 30 days post-procedure.
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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.
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Exit from operating room and up to 30 days post-procedure.
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Procedural Success
大体时间：Exit from operating room and up to 30 days post-procedure.
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Procedural success includes technical success with absence of major adverse events, no structural or functional failure, and reduction of mitral regurgitation to acceptable levels.
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Exit from operating room and up to 30 days post-procedure.
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Patient Success
大体时间：1 year post-index procedure.
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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.
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1 year post-index procedure.
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Blood Product Usage
大体时间：Perioperative through hospital discharge (an average of 4 days following the index procedure).
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Blood product usage intraoperatively or post-operatively following the index procedure, measured as the number of blood product units transfused.
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Perioperative through hospital discharge (an average of 4 days following the index procedure).
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Procedure Time
大体时间：During the index procedure.
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Time from first incision to incision closure (hours).
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During the index procedure.
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Operating Room Time
大体时间：During the index procedure.
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Time from entry into the operating room suite until exit from the operating room suite (hours).
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During the index procedure.
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Percentage of Subjects Receiving Mitral Valve Replacement (MVR)
大体时间：During the index procedure.
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Percentage of subjects receiving mitral valve replacement during the index procedure.
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During the index procedure.
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Composite Effectiveness Endpoint
大体时间：1 year post-index procedure.
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Freedom from all-cause mortality, re-intervention on the mitral valve, and recurrent moderate or severe mitral regurgitation.
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1 year post-index procedure.
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Discharged to Home vs Other Facility
大体时间：At hospital discharge (an average of 4 days following the index procedure).
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Discharge disposition following hospitalization, including discharge to home versus another facility.
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At hospital discharge (an average of 4 days following the index procedure).
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New York Heart Association (NYHA) Functional Class
大体时间：Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
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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.
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Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.
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Mitral Regurgitation Grade
大体时间：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.
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Measured by transthoracic echocardiogram.
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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.
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Left Ventricular End Diastolic Diameter (LVEDD)
大体时间：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.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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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.
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Left Ventricular End Systolic Diameter (LVESD)
大体时间：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.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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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.
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Left Ventricular End Diastolic Volume (LVEDV)
大体时间：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.
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Measured by transthoracic echocardiogram (mL).
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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.
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Left Ventricular End Systolic Volume (LVESV)
大体时间：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.
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Measured by transthoracic echocardiogram (mL).
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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.
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Left Ventricular Ejection Fraction (LVEF)
大体时间：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.
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Measured by transthoracic echocardiogram (%).
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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.
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Left Atrial Volume
大体时间：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.
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Measured by transthoracic echocardiogram (mL).
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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.
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Mitral Annular Septal-Lateral Dimension
大体时间：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.
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Measured by transthoracic echocardiogram (mm or cm per institutional echocardiographic convention).
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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.
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Right Ventricular Systolic Pressure (RVSP)
大体时间：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.
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Measured by transthoracic echocardiogram (mmHg).
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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.
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Mitral Valve Peak Gradient
大体时间：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.
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Measured by transthoracic echocardiogram (mmHg).
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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.
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Mitral Valve Mean Gradient
大体时间：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.
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Measured by transthoracic echocardiogram (mmHg).
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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.
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Tricuspid Valve Regurgitation (TVR) Grade
大体时间：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.
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Measured by transthoracic echocardiogram.
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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.
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Right Ventricular Function
大体时间：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.
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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).
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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.
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Ventilation Duration
大体时间：At extubation (an average of 2 hours following the index procedure).
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Total ventilation duration following the index procedure (hours).
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At extubation (an average of 2 hours following the index procedure).
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Intensive Care Unit Length of Stay
大体时间：At ICU discharge (an average of 1 day following the index procedure).
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Total intensive care unit length of stay following the index procedure (hours).
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At ICU discharge (an average of 1 day following the index procedure).
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Hospital Length of Stay
大体时间：At hospital discharge (an average of 4 days following the index procedure).
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Total hospital length of stay following the index procedure (days).
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At hospital discharge (an average of 4 days following the index procedure).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：James Gammie, MD、Johns Hopkins University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月8日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2029年7月1日
研究注册日期
首次提交
2026年7月6日
首先提交符合 QC 标准的
2026年7月20日
首次发布 (实际的)
2026年7月24日
研究记录更新
最后更新发布 (实际的)
2026年7月24日
上次提交的符合 QC 标准的更新
2026年7月20日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.