Health Condition 1: I060- Rheumatic aortic stenosis
Conditions
Interventions
Intervention1: Transcatheter Aortic Valve Replcement: eg., Transcatheter deployment in Orthotopic position,Transcatheter deployment in Huffnagelâ??s position, Surgical deployment in mitral position.
C
Sponsors
Meril Life Sciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: All candidates of this study must meet all of the following Inclusion criteria: 1.Subject above 18 years of age who or whose legal representative are willing to sign informed consent form to participate in the study 2.Patients must have co-morbidities such that the heart team concur that the predicted risk of operative mortality is >=15% and/or a minimum STS score of 10 3.Subject has senile degenerative aortic valve stenosis with echocardiographically derived criteria: mean gradient >40 mmHg or jet velocity greater than 4.0 m/s or an initial aortic valve area (AVA) of 4.Subject is symptomatic from his/her aortic valve stenosis, as demonstrated by the New York Heart Association (NYHA)Functional Class II or greater. 5.Subject or the subjectâ??s legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee of the respective clinical site. 6.The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.
Exclusion criteria
Exclusion criteria: Candidates will be excluded from the study if any of the following conditions are present: 1.Subjects who are not willing to provide informed consent form, or whose legal heirs object to participate the study 2.Pregnant and lactating female subjects 3.Evidence of an acute myocardial infarction 4.Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is non-calcified. 5.Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+). 6.Any therapeutic invasive cardiac procedure performed within 30 days of the index procedure, (or 6 months if the procedure was a drug eluting coronary stent/scaffold implantation). 7.Pre-existing prosthetic heart valve in any position, prosthetic ring, severe mitral annular calcification (MAC), severe (greater than 3+) mitral insufficiency, or Gorlin syndrome. 8.Blood dyscrasias as defined: leukopenia (WBC 9.Untreated clinically significant coronary artery disease requiring revascularization. 10.Hemodynamic instability requiring inotropic support or mechanical heart assistance. 11.Need for emergency surgery for any reason. 12.Hypertrophic cardiomyopathy with or without obstruction (HOCM). 13. Severe ventricular dysfunction with left ventricular ejection fraction (LVEF) 14.Echocardiographic evidence of intracardiac mass, thrombus or vegetation. 15.Active peptic ulcer or upper GI bleeding within the prior 3 months. 16.A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or sensitivity to contrast media, which cannot be adequately premedicated. 17.Native aortic annulus size 28mm as measured by echocardiogram. 18.Recent (within 6 months) cerebrovascular accident (CVA) or a Transient Ischemic Attack (TIA) 19.Renal insufficiency and/or end stage renal disease requiring chronic dialysis 20.Life expectancy 21.Significant aortic disease, including abdominal aortic or thoracic aneurysm defined as maximal luminal diameter 5cm or greater; marked tortuosity (hyperacute bend), aortic arch atheroma or narrowing (especially with calcification and surface irregularities) of the abdominal or thoracic aorta, severe "unfolding" and tortuosity of the thoracic aorta (applicable for transfemoral patients only). 22.IIio femoral vessel characteristics that would preclude safe placement of 22F or 24F introducer sheath such as severe obstructive calcification, severe tortuosity or vessels size less than 7 mm in diameter (applicable for transfemoral patients only). 23.Currently participating in an investigational drug or another device study. 24.Active bacterial endocarditis or other active infections. 25.Bulky calcified aortic valve leaflets in close proximity to coronary ostia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kaplan-Meier survivorship,Functional improvement from baseline as measured per NYHA functional classification, Effective Orifice Area (EOA) and Six minute walk test, Freedom from MACCRE, Evidence of prosthetic valve dysfunction, Length of index hospital stay, Total hospital days, Improved Quality of Life, Annual Kaplan-Meier survivorship calculationsTimepoint: the first-in-human feasibility and short-term clinical outcomes with a new balloon-expandable transcatheter heart valve (THV). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Freedom from major adverse cardiac cerebrovascular and renal events at 30 days, 6 and 12 months. 2)Evidence of prosthetic valve dysfunction (hemolysis, infection, thrombosis, severe paravalvular leak, or migration) at 30 days, 6 and 12 mos. 3)Length of index hospital stay. 4)Total hospital days from the index procedure to one year post procedure. 5)Improved Quality of Life (QOL) from baseline at 30 days, 6 and 12 months. 6)Improved valve function demonstrated by a responder analysis Timepoint: 1, 6 & 12 Months | — |
Countries
India
Contacts
Public ContactDr Ashok Thakkar
Fortis Escort
Outcome results
None listed