NCT03616678Unknown不适用
Evaluation of The Minimally Invasive VenTouch™ System in The Treatment of Functional Mitral Valve Regurgitation (FMR): OUS Feasibility Study
Mardil Medical23 个研究点 分布在 7 个国家目标入组 15 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 23
- 主要终点
- Evaluate SAE Rates
研究概览
简要总结
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR.
详细描述
This is a prospective, multi-center, single-arm study to evaluate safety and efficacy of the VenTouch System for treatment of subjects with functional MR enrolling up to 15 subjects who have been diagnosed with Grade 3-4 functional mitral valve regurgitation and deemed eligible per assessment by the inclusion/exclusion criteria. The duration of the study follow-up is 36 months from the time of therapy adjustment. Data from this trial may be utilized in support of a CE study in Europe and/or a pilot IDE study in the U.S. Follow-up testing will be performed at 1, 3, 6, 12, 24, and 36 months post-therapy adjustment.
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
- •Adults ≥18 years of age
- •Symptomatic FMR of grade moderately severe to severe (3 to 4) due to either ischemic or non-ischemic dilated cardiomyopathy with structurally normal leaflets determined by echocardiography (preferably with echocardiographic evidence of EROA ≥ 0.20 cm2)
- •NYHA Class II to IV
- •Left Ventricular Ejection Fraction (LVEF) 20%-50% determined by echocardiography
- •Treatment and compliance with optimal guideline-directed medical therapy for heart failure for at least 30 days
- •Subjects with a Class I indication for CRT implant according to current guidelines should have CRT implant prior to entry into the study. Subjects who have existing CRT implants may be included in the study if the implant has been in place for at least 90 days; reprogramming of an implanted CRT that results in increased biventricular pacing (from <92% to ≥92%) must be in place for at least 30 days.
- •Left Ventricular End Diastolic Diameter (LVEDD) of 55 to 80 mm as determined by echocardiography
- •Indexed Left Ventricular End Diastolic Diameter (LVEDDi) of 30 to 40 mm/m2 (where LVEDDi is calculated by LVEDD/Body Surface Area (BSA))
- •Subject is willing and available to return for study follow-up
- •Subject or legal representative understands and provides signed informed consent for participation in study
- •Acceptance of subject for trial enrollment after review of all subject baseline data by Study Selection Committee
排除标准
- •Life expectancy of less than 12 months due to conditions other than cardiac status
- •Anticipated need for LVAD or transplant within 12 months
- •Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- •American College of Cardiology / American Heart Association (ACC/AHA) Stage D heart failure
- •Six-minute walk distance < 150 meters
- •Identified need for any cardiovascular surgery
- •STS score that suggests prohibitive surgical risk as determined by Subject Selection Committee
- •Untreated clinically significant coronary artery disease
- •Any procedure, condition or cardiac anatomy that may impact or compromise the pericardial space (e.g. prior mitral valve surgery, CABG, epicardial pacing leads, pericarditis, or other procedure involving pericardial access)
- •Percutaneous coronary intervention, acute coronary syndrome (e.g. STEMI or non-STEMI myocardial infarction, unstable angina) or clinically significant cardiac events (e.g. hypotension, syncope, arrhythmias, embolism, heart failure exacerbation or any hospitalization) within 30 days of enrollment
- •Thoracic or cardiac surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis, pericarditis)
- •Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion)
- •Severe symptomatic carotid stenosis
- •Severe or sustained pulmonary hypertension, defined by resting pulmonary artery systolic (PAS) pressure ≥70 mmHg determined by echocardiography or right heart catheterization
- •Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction or moderate to severe TR
- •Hypotension (systolic pressure <90 mmHg)
- •Hemodynamic instability requiring inotropic support or mechanical heart assistance within 30 days
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, or any other structural heart disease causing heart failure other than dilated cardiomyopathy
- •UNOS status 1 heart transplantation
- •Creatinine > 2.5 mg/dL (221 µmol/L) and/or renal failure requiring dialysis
- •Stroke (cerebrovascular accident) or transient ischemic event (TIA) within 30 days of enrollment
- •Active systemic infection or bleeding
- •Autoimmune disorders and/or the use of immune suppression therapy
- •Females who are pregnant (as documented by HCG beta pregnancy test in females of child-bearing age) or lactating
- •Currently enrolled in another investigational drug or device study
- •Intra-Operative Exclusion Criteria:
- •Significant structural abnormality of the mitral valve (e.g. flail leaflets, ruptured or elongated chordae, prolapsed valve, perforated valve leaflets, significant calcification in the annulus, or calcification in the leaflets that restricts motion)
- •Signs/indications of ischemia
- •Intra-operative coronary angiography demonstrates that there is compression of the coronary arteries or reduction in coronary blood flow due to the VenTouch implant
结局指标
主要结局
Evaluate SAE Rates
时间窗: 1 Month
Evaluate Serious Adverse Event (SAE) rates at 1 month post-therapy adjustment
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures
时间窗: Intra-operative
Evaluate procedural feasibility through successful completion of implant and therapy adjustment procedures and intraoperative transesophageal echocardiographic (TEE) evidence of MR severity reduction (a minimum of one grade)
次要结局
- Evaluate SAE Rates(36 Months)
- Evaluate MR Severity(36 Months)
- Evaluate Changes in Patient Symptoms by NYHA(36 Months)
- Evaluate Reverse Ventricular Remodeling(36 Months)
- Evaluate Changes in Patient Functional Status by Six-Minute Walk(36 Months)
- Evaluate Changes in Patient Functional Status by KCCQ(36 Months)
研究者
研究点 (23)
Loading locations...
相似试验
Unknown
不适用
Evaluation of the Minimally Invasive VenTouch™ System in the Treatment of Functional Mitral Valve Regurgitation (FMR)Functional Mitral RegurgitationNCT02671799Mardil Medical15
已完成
不适用
VIRTUS: An Evaluation of the Vici™ Venous Stent System in Patients With Chronic Iliofemoral Venous Outflow ObstructionChronic Venous DisorderVenous Outflow ObstructionSymptomatic Venous Outflow Obstruction of Iliofemoral VeinNCT02112877Boston Scientific Corporation200
尚未招募
4 期
Vunakizumab in Adults with SpondyloarthritisSpondyloarthritis (SpA)NCT06770088Sun Yat-sen University880
已完成
不适用
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs ControlCentral Nervous System InfectionsPseudotumor CerebriNeurological DisorderObstetric Procedure PainOrthopedic Procedure PainPost-Dural Puncture HeadacheCancerNCT04796935IntuiTap Medical, Inc95
已完成
不适用
Pulsta® Transcatheter Pulmonary Valve Korean Multicenter StudyPulmonary Valve StenosisCongenital Heart DefectPulmonary Valve Insufficiency, CongenitalNCT03110861Taewoong Medical Co., Ltd.15