Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Subjects With Procedural Success During the First 30 Days
研究概览
简要总结
The primary objective 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 TEE-guided ePTFE cordal 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 cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
- •Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse
- •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
- •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 Transesophageal 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
研究组 & 干预措施
Harpoon Medical Transapical device TSD-5
This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.
干预措施: Harpoon Artificial ePTFE Chords (Device)
结局指标
主要结局
Number of Subjects With Procedural Success During the First 30 Days
时间窗: Procedure, discharge, and 30 days
To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.
Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days
时间窗: Procedure, Discharge and 30 Days
Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.
次要结局
- Subject's Severity of Mitral Regurgitation Over Time(6 Months, 12 Months, and 24 Months)
- Subject's Freedom From Serious Adverse Events Over Time(6 Months, 12 Months, and 24 Months)