CTRI/2023/02/049837招募中2 期
Clinical Investigation of the Foldax TRIA Mitral Valve
FOLDAX INDIA PRIVATE LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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
入选标准
- •1) 18 years or older
- •2) Is a candidate for mitral valve replacement with cardiopulmonary bypass
- •3) Is a candidate for mitral valve replacement due to severe mitral valve disease
- •4) No contraindication for anticoagulation treatment
- •5) Willing and able to comply with protocol requirements and are willing and able to
- •consent for the study
排除标准
- •1) Requires valve replacement other than mitral
- •2) Prior mitral valve surgery for valve replacement or valve repair (this does NOT include
- •percutaneous interventions i.e., Mitraclip,)
- •3) Required concomitant cardiovascular procedures except for CABG and/or COXMAZE if approved by the screening committee
- •4) Requires emergency surgery
- •5) Requires other planned surgery within 12 months of valve replacement
- •6) Active endocarditis or active myocarditis
- •7) Exhibits left ventricular ejection fraction = 20% as validated by diagnostic c procedure
- •prior to planned valve surgery
- •8) Acute preoperative neurological deficit defined as neurological deficit < 3 months prior
- •to enrollment
- •9) Life expectancy of less than 12 months
- •10) Enrolled in another investigational device or drug studies (enrolled patients may not
- •enroll in other studies)
- •11) Myocardial infarction, or severe cardiac adverse event who have not returned to
- •baseline for at least 30-days prior to enrollment
- •12) Aortic aneurysm measuring > 4.5cm or other medical condition that creates a higher
- •than usual risk of surgical complications
- •13) Has renal insufficiency as determined by creatinine (S-Cr) level as = 2.0 mg/dl or end stage renal disease requiring chronic dialysis at screening visit
- •14)Results for the following blood tests are not within normal limits: DDimer, Basic
- •Metabolic Panel Liver enzymes, Coagulation Profile – platelets, APTT, INR,
- •Fibrinogen, C-reactive protein (HSCRP) and ESR, and Troponin levels
- •15) Hematological disorders, patients must not have a hematocrit of < 4,000 µL
- •cells/thrombocytosis (platelet count >450x103/µL, or history of bleeding diathesis or
- •coagulopathy
- •16) Patients who are pregnant or expect to become pregnant in the 12 months following
- •implantation, or are lactating
- •17) Any other condition that, in the judgement of the investigator and screening committee,
- •makes the patient a poor candidate for the procedure, the study or compliance with the
- •protocol (includes vulnerable patient population, mental illness, addictive disease,
- •extensive travel away from the research center, COVID-19 related concerns)
- •18) Patients who have withdrawn after implantation may not re-enter
- •19) Intraoperatively it is determined that the patient anatomy is not compatible with the
研究者
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