Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
Conditions
Interventions
Intervention1: HYDRA Self Expanding Transcatheter Aortic Valve: The Hydra Aortic Valve and Delivery Catheter comprises of stent frame with pericardial leaflets, delivery catheter, and loading system.
Sponsors
Vascular Concepts Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject has given written study Informed Consent for participation prior to procedure 2. Age should be 65 years and above 3. High risk patients having STS score being =3%. Patients with an STS risk score that is 4. Aortic annulus diameter meets the range 17.0 mm-20.0 mm for Hydra 22, 20.0 mm-23.5 mm for Hydra 26 and 23.5 mm-27.0 mm for Hydra 30 as measured by CT conducted within the past 180 days, or echocardiogram (TEE 3D recommended) if medically contraindicated to CT 5. Patient has senile degenerative aortic stenosis associated with or without >mild aortic regurgitation with echocardiography derived aortic valve area of 40 mmHg or peak velocity greater >4.0 m/s or doppler velocity index (DVI) =0.25. All measurement taken by echo within 30 days of procedure 6. Patient has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater 7. Asymptomatic patients with AVA of 5.5 m/s, markedly elevated b-type natriuretic peptide, or severe pulmonary hypertension without other explanations 8. Has structurally normal cardiac anatomy 9. Willing by the subject /subject’s legal representative and able to comply with all required follow-up evaluation
Exclusion criteria
Exclusion criteria: 1. Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months 2. Patient has carotid artery disease requiring intervention 3. Patient has evidence of a myocardial infarction (MI) within the past 6 months 4. Patient has hypertrophic cardiomyopathy 5. Patients with congenital bicuspid aortic valve 6. Patients with associated severe mitral or tricuspid valvular regurgitation or moderate to severe mitral stenosis 7. Patient has aortic root angulation >70 degrees (horizontal aorta) 8. Patient has aortic root diameter of 36 mm 9. Patient refuses blood transfusion or surgical valve replacement 10. Patient has resting left ventricular ejection fraction (LVEF) 11. Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization 12. Patients with significant coronary artery disease (unprotected left main disease, multivessel disease with SYNTAX score greater than 22) 13. Patient has severe basal septal hypertrophy 14. Patient has had a percutaneous interventional or other invasive cardiac or peripheral procedure = 14 days of the index procedure 15. Patient has a history of or has active endocarditis 16. Patient has echocardiographic evidence of intracardiac mass, thrombus, or vegetation 17. Cardiac shock (vasopressor dependence or mechanical support) 18. Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance) 19. Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure 20. Patient with significant pulmonary disease as determined and documented by the Investigator 21. Patients with severe lung disease with FEV 1 22. Patients with severe PAH (Pulmonary arterial hypertension) with PAP (Pulmonary artery pressure) greater than 2/3rd of systemic pressure 23. Patient has significant chronic steroid use as determined and documented by the Investigator 24. Patient has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication 25. Patient has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265.5µmol/L) or eGFR 26. Patient iliac arteries have severe calcification, tortuosity ( >two 90 degree bends), diameter 27. Patient has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy) 28. Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation 29. Patient has significant aortic disease 30. Patients with non-calcified, byt fibrotic aortic valve 31. Patients with significant calcium in LVOT 32. Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries 33. Patients with pre-existing mechanical/bioprosthetic valve in any position 34. Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure 35. Patient with expected life expectancy less than 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Safety Endpoint: Cardiovascular mortality Defined as all CV deaths occurred in subjects attending the Hydra prosthesis implantation within 30 days post procedure. Primary Performance Endpoint: Device success at implantation (absence of procedural mortality + correct positioning of single prosthetic valve in proper anatomical position with mean gradient less than 20mmHg with absence of moderate or severe prosthetic valve regurgitation).Timepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| - All cause death (Cardiovascular and Non-Cardiovascular) - Acute kidney injury (AKI) - Bleeding - Myocardial Infarction (MI) - Vascular access site and access-related complications - Periprocedural encephalopathy - All stroke - Disabling stroke (Major Stroke) - Non-disabling stroke (Minor Stroke) - All TIA - Need for permanent pacemakerTimepoint: Discharge, 30 days and 6 months;Functional improvement from baseline Defined by: - Six Minute Walk Test - Effective Orifice Area (EOA) (Aortic Valve Area 1.2 cm2) and mean aortic valve gradient 20 mmHg without moderate or severe prosthetic valve ARTimepoint: 30 days and 6 months | — |
Countries
India
Contacts
Public ContactDr Praveen Chandra
Medanta - The Medicity Hospital
Outcome results
None listed