NL-OMON49193已完成不适用
Tiara* Transcatheter Mitral Valve Replacement Study - TIARA-II 047-CPT-003
eovasc Medical Inc.0 个研究点目标入组 30 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
- 已完成
- 发起方
- 入组人数
- 30
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
- •1. Age 18 years or older.
- •2. NYHA Class II to ambulatory Class IV.
- •3. Severe mitral regurgitation (reference Section 20)
- •4. High surgical risk for open mitral valve surgery as determined by the
- •examining cardiac surgeon and the local institutional Heart Team (consisting of
- •an interventional cardiologist and cardiac surgeon, at a minimum) based on an
- •STS mitral valve replacement PROM >=8% and/or the Heart Team assessing the risk
- •of operative mortality >=8% (modified from 2014 AHA/ACC Valvular Heart Disease
- •Guidelines definition of high risk).
- •5. Subject meets the initial anatomical eligibility criteria for annulus size
- •(site measurement of diameter <50 mm) for the available size(s) of the Tiara
- •Mitral Valve based on CT scan or TTE and/or TEE.
- •6. The subject has been informed of the nature of the investigational device,
- •required study follow-up procedures and visits and agrees to participate, and
- •has provided written informed consent.
排除标准
- •1. Deemed too frail by objective frailty assessments or with severe
- •comorbidities such that the subject is unlikely to benefit from the procedure
- •as determined by the local institutional Heart Team.
- •2. Previous cardiac procedures:
- •a. PCI within 30 days of enrollment
- •b. Drug Eluting Stent implantation within 30 days of enrollment
- •c. Bare Metal Stent implantation within 30 days of enrollment
- •d. Coronary artery bypass graft (CABG) within 30 days of enrollment
- •e. Any surgical or transcatheter mitral valve replacement that would interfere
- •with the placement of the TiaraMitral Valve
- •f. TAVR within 30 days of enrollment
- •g. Mitral valve repair surgery within 30 days of enrollment
- •h. Cardiac transplant
- •i. CRT/ICD implant within 30 days of enrollment
- •3. Evidence of any myocardial infarction (MI) within 30 days of enrollment.
- •4. Cardiac structures:
- •a. Ventricular dysfunction with ejection fraction <= 25% within 30 days of
- •b. Left ventricular outflow tract (LVOT) obstruction
- •c. Evidence of left atrial and/or left ventricular thrombus (within 90 days of
- •enrollment), vegetation or cardiac mass
- •d. Apex not amenable to transapical access as deemed by the examining cardiac
- •e. Aortic, tricuspid or pulmonary valve disease requiring intervention
- •f. Presence of a hemodynamically significant intracardiac shunt
- •g. Clinically significant untreated coronary artery disease (CAD) requiring
- •revascularization
- •5. Cerebrovascular accident (CVA) and/or transient ischemic attack (TIA) within
- •30 days of enrollment or Modified Rankin Scale >=4 disability.
- •6. Subjects who are on chronic dialysis or who have a serum creatinine value >
- •3.0 mg/dL (265.2 µmol) or eGFR < 35 ml/min within 30 days of enrollment.
- •7. Pregnant, currently breastfeeding, or planning pregnancy within next 12
- •8. Documented bleeding or coagulation disorders which limit anticoagulant
- •9. Documented recent (within 90 days of enrollment) GI bleeding requiring
- •medical intervention (e.g., blood transfusion).
- •10. Active infections requiring antibiotic therapy.
- •11. Known hypersensitivity or contraindication to:
- •a. Aspirin, or heparin, or clopidogrel (Plavix)
- •b. Allergy to contrast media which cannot be managed medically
- •c. Nitinol or its components (e.g., nickel or titanium)
- •12. Subject is unable to undergo transesophageal echocardiography (TEE) during
- •the implantation procedure.
- •13. Subject is currently participating in another investigational drug or
- •device clinical trial that may interfere with the results of either trial.
- •(Note: Patients
- •enrolled in a clinical trial involving products that are currently commercially
- •available are eligible).
- •14. Need for emergent or urgent surgery for any reason or any planned cardiac
- •surgery within the next 12 months.
- •15. Subjects with a life expectancy of less than 12 months due to noncardiac
- •16. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic
- •support or mechanical hemodynamic support.
- 另有 1 项未显示
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