Health Condition 1: I352- Nonrheumatic aortic (valve) stenosis with insufficiency
Conditions
Interventions
Intervention1: Surgical Aortic Valve
: Surgical Aortic Valve
Frequency: Once
Duration: Lifetime
Device brand name: Nexcrea Dehydrated Surgical Aortic Valve.
Control Intervention1: NIL: NIL
Sponsors
Onecrea Medical India Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient must be 55 years or older. 2. Patient provides written informed consent and agrees to all follow-ups at clinical investigational sites that are participating in the OneCrea SAVR study. 3. Patient life expectancy is at least 1 year. 4.Diagnosed with aortic disease requiring valve replacement based on pre-operative evaluation (Medical history, physical examination, 2D echocardiography, and CBC). 5. The physician considers the patient a candidate for a bioprosthetic heart valve. 6. STS scores should be less than 4 percent (Low Risk) 7. Patient has significant Aortic stenosis or Aortic regurgitation, or patient is subjected for Aortic Valve replacement due to combine aortic lesion (stenosis and regurgitation). 8. Patient anatomy is eligible for SAVR treatment with the investigational device per the Indications in the Instructions for Use. 9. The patient is in a geographic location that will enable the patient to return to the study site for follow-up examinations. 10. The patient or patient’s legal representative signs an informed consent form prior to enrolment.
Exclusion criteria
Exclusion criteria: 1. Has active endocarditis / myocarditis or endocarditis / myocarditis within 3 months to the scheduled aortic valve replacement surgery. 2. Has renal insufficiency as determined by creatinine (S-Cr) level greater than or equal to 2.5 gram per decilitre 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 abnormal calcium metabolism and hyperparathyroidism. 7. Exhibits left ventricular ejection fraction less than or equal to 30 percent as validated by diagnostic procedure prior to planned valve surgery. 8. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation. 9. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery. 10. Documented leukopenia (WBC less than 3.5 x 10³ per microlitre), acute anemia (Hgb less than 10.0 gram per decilitre or 6 millimoles per litre) or thrombocytopenia (platelet count less than 50 x 10³ per microlitre) accompanied by history of bleeding diathesis and coagulopathy. 11. Has prior organ transplant or is currently an organ transplant candidate. 12. The patient is currently participating in a study of an investigational drug or device. 13. Pregnant (female subject of childbearing potential only), lactating or planning to become pregnant during the duration of participation in study. 14. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant material. 15. Requires concomitant left ventricular assist device (LVAD) placement. 16. Currently unable to give voluntary informed consent. 17. A known hypersensitivity or contraindication to bivalirudin, polyetheretherketone (PEEK) material, prasugrel, heparin, clopidogrel, acetyl salicylic acid, or contrast material. 18. The patient has a malignancy or other disease with a poor 2-year prognosis which may interfere with the ability to conduct follow-up (i.e. metastatic cancer). 19. The patient is a known alcohol or drug abuser. 20. The patient is currently participating in the study of an unapproved drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Aortic ValveTimepoint: Baseline, procedure, discharge, 1month, 3 months, 6 months and at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Performance outcome of Aortic ValveTimepoint: Baseline, procedure, discharge, 1month, 3 months, 6 months and at 12 months. | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
CliniExperts Research Services Pvt Ltd
Outcome results
None listed