Health Condition 1: I350- Nonrheumatic aortic (valve) stenosis
Conditions
Interventions
Intervention1: Crea Aortic Valve: Crea Aortic Valve Self Expanding Transcatheter Aortic Valve
Frequency- Once
Duration- Lifetime
Control Intervention1: NIL: NIL
Sponsors
Onecrea Medical India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female at least 18 years of age. 2. Patient provides written informed consent and agrees to all follow-up. 3. Patient life expectancy at least 1 year. 4. Subjects with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy. 5. Patient anatomy is eligible for TAVR treatment with the investigational device per the Indications in the Instructions for Use. The patientâ??s aortic arch anatomy requirements are as per communication with the Investigator during training. Patient must present the aortic arch of greater than 80 mm diameter or 100 mm shaft should be able to fit in a straight line in the aorta at the arch.
Exclusion criteria
Exclusion criteria: 1. Mechanical or biologic prosthesis in the aortic position. 2. Known hypersensitivity or contraindication to aspirin, heparin (HIT/HITTS) and bivalirudin, ticlopidine, clopidogrel, Nitinol (Titanium or Nickel), or sensitivity to contrast media, which cannot be adequately premedicated. 3. Known allergy to any device component. 4. Bicuspid aortic valve 5. Ongoing sepsis, including active endocarditis 6. Pregnant (female of childbearing potential only). 7. Patient ejection fraction 8. Patient expected to undergo for coronary intervention within 12 Months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Related: 1. Technical Success at exit from procedure room. 2. Device Success at 30 days, or in-hospital if 30-day data are not available. 3. Early Safety at 30 days. 4. Clinical Efficacy at 3-months 5. Clinical Efficacy at 6-months 6. Clinical Efficacy at 12-months. All cause mortality in 30 days. Timepoint: 30 days, 1 month, 3 month , 6 month and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-Reported Outcomes: 1. NYHA Class (at each follow-up, & change from baseline). 2. 6-Minute Walk Test (6MWT [at 6-Mo & 12-Mo, & change from baseline]). 3. Kansas City Cardiomyopathy Questionnaire (KCCQ [at 12-Mo, with change from baseline]).Timepoint: 30 days, 1 month, 3 month , 6 month & 12 months | — |
Countries
India
Contacts
Public ContactDr Ashwini Kumar
Medanta - The Medicity, Gurgaon
Outcome results
None listed