Health Condition 1: I080- Rheumatic disorders of both mitraland aortic valves
Conditions
Interventions
Intervention1: Dafodil-Pericardial Bioprosthesis: Dafodil-Pericardial Bioprosthesis is used in patients who require replacement of their natural or prosthetic aortic or mitral valve.
Control Intervent
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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 v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MACE, Cardiovascular mortality, Stroke and Transient Ischemic Attack (TIA), Major bleeding, Minor bleeding, Acute kidney injury(AKIN classification), Valve thrombosis, Structural valve deterioration, Prosthetic valve Endocarditis, Major paravalvular leak, Conduction disturbances and arrhythmias, Nonstructural valve dysfunction, Mitral valve apparatus damage or dysfunction, Aortic valve apparatus damage or dysfunction, Explant, Hemolysis, Trial valve-related reoperationTimepoint: Baseline, 1 month, 6 months, 1 year, 2 years,3 years,4 years and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| NYHA, Quality of life, Hemodynamic performance, Device successTimepoint: Baseline, 1 month, 6 months, 1 year, 2 years,3 years,4 years ,and 5 years | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Meril Life Sciences Pvt Ltd
Outcome results
None listed