Health Condition 1: null- Severe aortic stenosis in high risk patients
Conditions
Interventions
Intervention1: Hydra Transaortic valve: Hydra Transaortic valve
Intervention2: HYDRA: HYDRA Self Expanding
Transcatheter Aortic Valve
Control Intervention1: nil: nil
Control Intervention2: NIL: NIL
Sponsors
VASCULAR CONCEPTS LTD
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must meet the following criterias to be included: 1.Subject has given written study Informed Consent for participation prior to procedure. 2.Greater than 18 years of age. 3.Aortic annulus diameter meets the range 18 mm-20 mm for Hydra 22, 20 mm-24 mm for Hydra 26 and 24 mm-28 mm for Hydra 30 as measured by CT conducted within the past 120 days, or echocardiogram (TEE 3D recommended) if medically contraindicated to CT. 4. Patient has senile degenerative aortic stenosis or aortic regurgitation with echocardiography derived mean gradient >40mmHg or jet velocity greater than 4.0 m/s or an initial valve area of 5. Patient has symptomatic aortic stenosis or aortic regurgitation as demonstrated by NYHA Functional Classification of II or greater. 6.Patient is deemed high operable risk and suitable for TAVI. 7.Patientâ??s predicted operative mortality or serious, irreversible morbidity risk is 8. Patient has good size access vessel,atleast 6mm. 9.Has structurally normal cardiac anatomy. 10. Willing by the subject /subjectâ??s legal representative and able to comply with all required follow-up evaluation.
Exclusion criteria
Exclusion criteria: Subjects should be excluded if the following criteria are met: 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. Patient has a native aortic valve that is congenitally uni-cuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography. 6. Patient has mitral or tricuspid valvular regurgitation ( > grade III) 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. Patient has severe basal septal hypertrophy. 13. Patient has had a percutaneous interventional or other invasive cardiac or peripheral procedure 14. Patient has a history of or has active endocarditis. 15. Patient has echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 16. Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance). 17. Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure. 18. Patient with significant pulmonary disease as determined and documented by the Investigator. 19. Patient has significant chronic steroid use as determined and documented by the Investigator. 20. Patient has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication. 21. Patient has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265.5μmol/L) or end-stage renal disease requiring chronic dialysis. 22. Patient iliac arteries have severe calcification, tortuosity ( >two 90 degree bends), diameter 23. Patient has blood dyscrasias (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy). 24. Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation. 25. Patient has significant aortic disease 26. Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the ileo-femoral arteries. 27. Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure 28. Patient has a life expectancy 29. Subject has other medical, social or psychological conditions that, in the opinion of the Principal Investigator, preclude the subject from study participation. 30. Patient has a known allergy to contrast media, nitinol alloys or bovine tissue. 31. Active infection requiring ongoing treatment; 32. History of any cognitive or mental health status that would interfere with study participation. 33. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality in 30 days. 30-day mortality of procedure is defined as all deaths occurred in subjects attending the Hydra prosthesis implantation within 30 days post procedure. All deaths include in-hospital mortality, cardiac death, valve-related death, and death of unknown cause. Timepoint: 30 days 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality ,Disabling stroke ,Non-disabling stroke ,Acute kidney injury , Bleeding ,Myocardial Infarction , Vascular access site and access-related complications ,Periprocedural encephalopathy, All stroke , NYHA Functional Classification ,Six minutes walk , Effective Orifice Area and mean aortic valve gradient 20 mmHg without moderate or severe prosthetic valve .Timepoint: 30 days, 3 months and 6 months | — |
Countries
India
Contacts
Public ContactDr Praveen Chandra
Medanta Medicity Gurgaon
Outcome results
None listed