CTRI/2017/07/009008进行中（未招募）2 期
A prospective, multi-center, single-arm clinical study to evaluate safety and performance of the Dafodil Pericardial Bioprosthesis in patients who require replacement of their natural or prosthetic aortic or mitral valve. - Dafodilâ?¢ â?? 1
Meril Life Sciences Pvt Ltd0 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
- 进行中（未招募）
- 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
- •Inclusion Criteria for Aortic Valve:
- •1. Patient must be 18 years or older.
- •2. Patient must provide written informed consent prior to study procedures.
- •3. STS scores should be less than 4 percent (Low Risk)
- •4. Patient must agree to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the Dafodil-1 study.
- •5. Diagnosed with aortic disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, echocardiography and CBC).
- •6.Patient has significant Aortic stenosis or Aortic regurgitation or patient is subjected for Aortic Valve replacement due to combine aortic lesion (stenosis and regurgitation).
- •(Reference: European society of Cardiology (ESC)/ American Society of Echocardiography (ASE) Guidelines - 2017)
- •7. Scheduled to undergo planned aortic valve replacement with or without concomitant bypass surgery or other valvular surgeries.
- •Inclusion Criteria for Mitral Valve:
- •1. Patient must be 18 years or older.
- •2. Patient must provide written informed consent prior to study procedures.
- •3. STS scores should be less than 4 percent (Low Risk)
- •4. Patient must agree to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations at clinical investigational sites that are participating in the Dafodil-1 study.
- •5. Diagnosed with mitral valve disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, echocardiography and CBC).
- •6. Patient has significant Mitral Stenosis or Mitral Regurgitation or patient is subjected for Mitral Valve replacement due to combine mitral lesion (stenosis and regurgitation).
- •(Reference: European society of Cardiology (ESC)/ American Society of Echocardiography (ASE) Guidelines - 2017)
- •7. Scheduled to undergo planned mitral valve replacement with or without concomitant bypass surgery or other valvular surgeries.
排除标准
- •Exclusion Criteria for Aortic Valve:
- •A subject meeting any of the following criteria shall be excluded.
- •1. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled aortic replacement surgery.
- •2. Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per deciliter or end-stage renal disease requiring chronic dialysis at screening visit.
- •3. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or TIA within 6 months (180 days) prior to planned valve surgery.
- •4. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery.
- •5. Has presence of non-cardiac disease limiting life expectancy to less than 5 years.
- •6. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM)
- •7. Diagnosed with abnormal calcium metabolism and hyperparathyroidism.
- •8. Exhibits left ventricular ejection fraction less than or equal to 20 percent as validated by diagnostic procedure prior to planned valve surgery.
- •9. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation.
- •10. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery.
- •11. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 grams per deciliter or 6 milimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy.
- •12. Has prior organ transplant or is currently an organ transplant candidate.
- •13. The patient is currently participating in a study of an investigational drug or device.
- •14. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study.
- •15. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material.
- •16. Requires concomitant left ventricular assist device (LVAD) placement.
- •17. Currently unable to give voluntary informed consent
- •18. A known hypersensitivity or contraindication to bivalirudin, nitinol, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material.
- •Exclusion Criteria for Mitral Valve:
- •A subject meeting any of the following criteria shall be excluded.
- •1. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled mitral valve replacement surgery.
- •2. Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per deciliter or end-stage renal disease requiring chronic dialysis at screening visit.
- •3. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or TIA within 6 months (180 days) prior to planned valve surgery.
- •4. Has acute myocardial infarction (MI) within 30 days prior to planned valve surgery.
- •5. Has presence of non-cardiac disease limiting life expectancy to less than 5 years.
- •6. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM).
- •7. Diagnosed with abnormal calcium metabolism and hyperparathyroidism.
- •8. Exhibits left ventricular ejection fraction less than or equal to 20 percent as validated by diagnostic procedure prior to planned
研究者
相似试验
进行中（未招募）
2 期
A prospective clinical trial to evaluate the efficacy and safety of 7-mm-diamter covered biliary metal stentPancreatic cancerJPRN-jRCTs042200064Ishiwatari Hirotoshi38
已完成
3 期
Clinical trial on Ayurvedic product for viral and bacterial infectionsCTRI/2020/07/026434VENKAT PHARMA
已完成
4 期
A prospective, multicentric, single arm clinical study to evaluate the effect of saroGlitazar on non HDL-ChoLesterol in patIents with Diabetic Dyslipidaemia inadequately controllEd with diet, exeRcise and statin.(SAROGLITAZAR)CTRI/2016/08/007126Dr Upendra Kaul104
已完成
3 期
MDT-1118 Japan DT StudyAdvanced Heart FailureJPRN-UMIN000036550Medtronic Japan Co., Ltd10
已完成
3 期
A Prospective, Multicenter, Single-arm Clinical Trial of Jetstream Atherectomy System for the Treatment of Japanese Patients with Symptomatic Occlusive Atherosclerotic Lesions in the Superficial Femoral and/ or Proximal Popliteal ArteriesPeripheral Arterial DiseaseJPRN-UMIN000036056Boston Scientific Japan K.K.31