Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 8
- 主要终点
- Subject's Procedural Success During the First 30 Days
研究概览
简要总结
The purpose of this study is to evaluate the safety and performance of the Harpoon Medical device. It is anticipated, that the Harpoon Medical device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
详细描述
The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Patient referred for mitral valve surgery
- •Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure
- •Estimated post-ePTFE chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
- •Degenerative mitral valve disease
- •Patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation
- •Women of child-bearing potential have a negative pregnancy test
排除标准
- •Age < 18 years
- •Infective endocarditis
- •Anterior or bileaflet prolapse
- •Functional MR
- •History of Mediastinal Radiation
- •Inflammatory (rheumatic) valve disease
- •Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
- •Symptomatic coronary artery disease
- •Cardiogenic shock at the time of enrollment
- •ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
- •Evidence of cirrhosis or hepatic synthetic failure
- •Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
- •Severe pulmonary hypertension (PA systolic pressure > 70 mmHg)
- •Previous cardiac surgery, or surgery on the left pleural space
- •Left ventricular, atrial or appendage thrombus
- •Severely calcified mitral leaflets
- •Recent stroke (< 6 months) with permanent impairment
- •EuroScore (for mitral valve repair) > 8%
- •Patients with contraindications to Transoesophageal echocardiography
- •Severe left or right ventricular dysfunction
- •NYHA Class IV
- •Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2)
- •Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)
- •Patient with non-cardiac co-morbidities and life expectancy < 1 year
- •Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures
结局指标
主要结局
Subject's Procedural Success During the First 30 Days
时间窗: End of procedure through 30 days
Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to \</=moderate at the conclusion of the procedure and at 30 days post-procedure.
Subject's Serious Adverse Events (SAE) Through Discharge
时间窗: Discharge, an average of 5 days post implant
Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.
Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days
时间窗: Procedure and 30 days
Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.
次要结局
- Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days(6 months, 12 months, 18 months, 24 months, 30 months, and 36 months)
- Subject's Severity of Mitral Regurgitation Over Time(6 months, 12 months, 18 months, 24 months, 30 months, and 36 months)