CTRI/2022/01/039144招募中2 期
Clinical Investigation for the Foldax TRIA Aortic Heart 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. Is 45 years or older
- •2. Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
- •3. Agrees to attend all follow-up assessments for up to month 12 and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
- •4. Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations
排除标准
- •1 Requires multiple valve replacement / repair
- •2 Requires emergency surgery
- •3 Has had prior valve surgery
- •4 Requires a surgical procedure outside of the cardiac area
- •5 Requires cardiac procedure other than a CABG, or aortic root enlargement (allowed to
- •optimize the fit and placement of the TRIA Heart Valve if needed).
- •6 Requires or are planning another unrelated surgery within 12 months of undergoing
- •implantation of the study device
- •7 Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
- •8 Has renal insufficiency as determined by creatinine (S-Cr) level as >= 1.5 mg/dl or endstage
- •renal disease requiring chronic dialysis at screening visit
- •9 Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient
- •ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery
- •10 Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
- •11 Has life expectancy to less than 12 months
- •12 Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients
- •who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
- •13 Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
- •14 Echocardiographic left ventricular ejection fraction <25%
- •15 Echocardiographic evidence of an intra-cardiac thrombus or vegetation
- •16 Hemodynamic or respiratory instability requiring inotropic support, mechanical
- •circulatory support, or mechanical ventilation within 30 days prior to planned valve
- •17 Documented leukopenia (WBC < 4.0 x 103/μL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/μL) or history of bleeding diathesis or coagulopathy
- •18 Has prior organ transplant or is currently an organ transplant candidate
- •19 Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
- •20 Pregnant, lactating or planning to become pregnant during the duration of participation in trial
- •21 Currently incarcerated or unable to give voluntary informed consent
- •22 Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
- •23 Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
- •24 Tests positive for an active infection with SARS-CoV-2 (COVID-19)
- •25 Currently diagnosed as uncontrolled diabetes mellitus (Random BSL > 300 mg/dl)
研究者
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