NCT07726173招募中不适用
Transventricular Off-pump Mitral Valve Repair (TRANSOM)
Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 175 人开始时间: 2026年6月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Primary Safety Endpoint: Composite Freedom from Major Adverse Events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Safety Endpoint: Composite Freedom from Major Adverse Events
时间窗: 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.
Primary Effectiveness Endpoint: Composite Freedom from Death, Recurrent mitral regurgitation (MR), and Re-intervention
时间窗: 1 year post-index procedure.
Freedom from all-cause mortality, recurrent moderate or severe mitral regurgitation, and re-intervention on the mitral valve.
次要结局
- Technical Success(Exit from operating room and up to 30 days post-procedure.)
- Procedural Success(Exit from operating room and up to 30 days post-procedure.)
- Patient Success(1 year post-index procedure.)
- Blood Product Usage(Perioperative through hospital discharge (an average of 4 days following the index procedure).)
- Procedure Time(During the index procedure.)
- Operating Room Time(During the index procedure.)
- Percentage of Subjects Receiving Mitral Valve Replacement (MVR)(During the index procedure.)
- Composite Effectiveness Endpoint(1 year post-index procedure.)
- Discharged to Home vs Other Facility(At hospital discharge (an average of 4 days following the index procedure).)
- New York Heart Association (NYHA) Functional Class(Baseline and at 30 days, 12, 24, 36, 48, and 60 months post-procedure.)
- Mitral Regurgitation Grade(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)(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)(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)(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)(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)(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(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(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)(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(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(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(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(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(At extubation (an average of 2 hours following the index procedure).)
- Intensive Care Unit Length of Stay(At ICU discharge (an average of 1 day following the index procedure).)
- Hospital Length of Stay(At hospital discharge (an average of 4 days following the index procedure).)
研究者
研究点 (1)
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