Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - EFS/CE Mark Study for the Harpoon Medical Device in Poland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 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 purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant 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 chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
详细描述
The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.
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
- •All subjects referred for mitral valve surgery
- •Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method.
- •Age > 18 years
- •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
- •Subject 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
- •Able to sign informed consent
排除标准
- •Age < 18 years
- •Infective endocarditis
- •Anterior or bileaflet prolapse
- •Functional mitral regurgitation
- •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%
- •Subjects 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 Device TSD-5
This is a prospective, nonrandomized, single-centered European study designed single arm study to demonstrate the performance and safety of the Harpoon Medical TSD-5 in Subjects with degenerative mitral regurgitation.
干预措施: Harpoon Medical Device (Device)
结局指标
主要结局
Number of Subjects With Procedural Success During the First 30 Days
时间窗: 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 8 days post implantation
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 through 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)