NL-OMON50054撤回不适用
A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitation - Millipede Feasibility Study
Boston Scientific Cooperation International0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •IC1: Subject is 18 Years of age or older
- •IC2: Subject (or legal guardian) understands the trial requirements and the
- •treatment procedures and provides informed consent before any trial -specific
- •tests or procedures are performed
- •IC3: Subject has moderate to severe (3+) or severe (4+) functional mitral
- •regurgitation(a) confirmed by the echocardiography core lab.
- •IC4: Subject is symptomatic (NYHA Class II-IV) despite guidelines directed
- •medical therapy, including CRT if indicated
- •IC5. The local site heart team concurs that mitral valve surgery will not be
- •offered as a first-line treatment option
- •IC6. Subject is a candidate for annuloplasty based on the criteria below as
- •assessed by the investigative site (and confirmed by the Case Review
- •Committee):
- •LVEF >= 25%
- •LVEDD <= 65 mm
- •Coaptation distance (i.e. tenting height) < 10 mm
- •Absence of posterior wall aneurysm
- •(a): Assessment per the American Society of Echocardiography mitral
- •regurgitation grading criteria [24, 25]
- •Abbreviations: CRT=cardiac resynchronization therapy; LVEDD=left ventricular
- •end diastolic diameter; LVEF=left ventricular ejection fraction; NYHA=New York
- •Heart Association
排除标准
- •EC1. Subject has severe calcification of the mitral annulus or leaflets, other
- •anatomic features that makes the patient unsuitable for annuloplasty with the
- •Millipede System in the judgment of the treating physician or subject does not
- •have suitable mitral annular diameter (determined by computed tomography) as
- •per the Instructions For Use).
- •EC2. Transfemoral venous and transseptal access determined not to be feasible
- •EC3. Subject is on the waiting list for a transplant or has had a prior heart
- •EC4. Subject has had a cerebrovascular accident (CVA) or transient ischemic
- •attack (TIA) within 30 days prior to study enrollment
- •EC5. Subject has had any percutaneous coronary, carotid, or other endovascular
- •intervention within 30 days prior to study enrollment
- •EC6. Subject has had carotid surgery within 30 days prior to study enrollment
- •EC7. Subject has had any open coronary or vascular surgery (other than carotid
- •surgery) within 3 months prior to study enrollment
- •EC8. Subject has had a cardiac resynchronization therapy (CRT) device
- •implantation within 3 months prior to study enrollment
- •EC9. Subject has untreated clinically significant coronary artery disease
- •requiring revascularization
- •EC10. Any planned cardiac surgery within the next 12 months
- •EC11. Need for emergent or urgent surgery for any reason
- •EC12. Subject has severe aortic valve stenosis and/or aortic valve
- •regurgitation
- •EC13. Subject has physical evidence of right-sided congestive heart failure
- •(CHF) plus echocardiographic evidence of moderate or severe right ventricular
- •dysfunction and/or severe tricuspid valve regurgitation
- •EC14. Subject has the presence of prosthetic heart valve in any position
- •EC15. Subject has renal insufficiency (eGFR <20 mL/min) and is not on dialysis
- •EC16. Subject has a life expectancy less than 12 months
- •EC17. Subjects in whom trans-esophageal ECHO/Doppler is contraindicated or in
- •which mitral regurgitation is not measurable by transthoracic echocardiogram
- •EC18: Subject has a prior history of atrial septal defect (ASD) closure or
- •patent foramen ovale (PFO) closure.
- •EC19: Subject has a fixed pulmonary artery systolic pressure >70 mmHg.
- •EC20: Subject has known hypersensitivity or contraindication to protocol
- •required procedural or post procedural medication (e.g., anticoagulation
- •therapy) or hypersensitivity to nickel or titanium
- •EC21. Subject has known hypersensitivity to contrast that cannot be adequately
- •premedicated
- •EC22. Female subject who is breast feeding or pregnant or planning to become
- •pregnant within the study period.
- •EC23. Subject is participating in another investigational drug or device study
- •that has not reached its primary endpoint or subject intends to participate in
- •another investigational device clinical trial within 12 months after index
- •EC24. Subject has a history of endocarditis within 6 months of index procedure
- •or evidence of an active systemic infection or sepsis.
- •EC25. Subject has oxygen-dependent chronic obstructive pulmonary disease.
- •EC26. Subject has documented severe liver disease.
- •EC27. Subject has Hgb <8 g/dL, platelet count <50,000 cells/mm3 or >700,000
- •cells/mm3, or white blood cell count <1,000 cells/mm3.
- •EC28. Subject has any evidence of intracardiac thrombus.
研究者
相似试验
尚未招募
不适用
A Study To Evaluate The Safety And Feasibility Of Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) In Patients With Coronary Artery Disease Undergoing Native Vessel InterventioCoronary Artery DiseaseCoronary Atherosclerosis10011082NL-OMON34428Miracor medical systems10
已完成
不适用
A STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF FOCAL EPIRETINAL RADIOTHERAPY AND RANIBIZUMAB (LUCENTIS®) FOR THE TREATMENT OF SUBFOVEAL CHOROIDAL NEOVASCULARIZATION (CNV) SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD)-H31H31PER-099-07EOVISTA INC.,
已完成
不适用
Study to evaluate the safety and feasibility of the STENTYS Balloon Delivery System (STENTYS-BDS).Coronary artery stenosiscoronary atherosclerosis1001108210007593NL-OMON41177STENTYS20
已完成
不适用
STUDY TO EVALUATE THE SAFETY AND VIABILITY OF THE IMPLEMENTATION OF NT-503 IN THE VITTURAL CAVITY FOR THE TREATMENT OF SUBFOVEAL COROID NEOVASCULARIZATION (NVC) SECONDARY TO AGE-ASSOCIATED MACULAR DEGENERATION (DMAE)PER-163-08EUROTECH,
已完成
不适用
A Prospective Safety and Feasibility Study of the RejuvenAir* System Metered Cryospray Therapy for Chronic Bronchitis Patients.Chronic BronchitisNL-OMON42706CSA MEDICAL, INC.15