Patients with severe symptomatic native aortic valve stenosis.
Conditions
Interventions
30 patients will be submitted to Transcatheter Valve Aortic Replacement.
Patient data will be followed at 30 days, 6 months, 1, 2, 3, 4 and 5 years post-implant.
All visits are in the hospital. Bel
adverse events occurrence
Cardiac medications evaluation
angina status
neurological evaluation in case of stroke or change in neurological status
electrocardiogram
blood exams.
6 months visit: Physical examination
neurological evaluation in case of stroke or change in neurological status.
1, 2, 3, 4 and 5 years visit: Physical examination
transthoracic echocardiogram.
Device
Procedure/surgery
Sponsors
Instituto Dante Pazzanese
Instituto Dante Pazzanese
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age > or = 18 years; Understand the implications of participating in the study and provide informed consent; Be suitable candidate for surgical aortic valve replacement; Comply with specified follow-up evaluation and be contacted by telephone; Present severe aortic stenosis: AVA 4 m/sec or mean gradient > 40 mmHg; Present cardiac symptoms: > or = NYHA Class II; Have co-morbidities associated with an increased surgical risk profile: (1) EuroSCORE > or = 20% or STS > or = 8% or (2) other high surgical risk factors as determined by the Heart Team (e.g. porcelain aorta, extreme frailty, liver disease, etc.); Have aortic annulus diameter > or = 22 mm and < 26 mm, assessed by both trans-thoracic echocardiography and by CTA; Have peripheral vessels (common femoral and iliac arteries) of acceptable size, tortuosity, and calcification to accommodate the 12Fr catheter system
Exclusion criteria
Exclusion criteria: Congenital unicuspid or bicuspid valve, or noncalcified aortic valve; Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation > or = 3+); Active or recent (within 6 months) endocarditis; Other active infections; Recent MI ( 3+) mitral regurgitation; Blood dyscrasias as defined: leukopenia (WBC 3.0) and/or end stage renal disease requiring chronic dialysis; Severe aortic disease, including abdominal aortic or thoracic aneurysm (lumen diameter > 5cm), marked tortuosity, or severe aortic arch atheroma; Aortic annulus diameter or = 26 mm, assessed by trans-thoracic echocardiography and CTA; Peripheral vessels (common femoral and iliac arteries) NOT of acceptable size, tortuosity, and calcification to accommodate the 12Fr catheter system (> or = 4mm diameter); Life expectancy < 12 months due to non-cardiac co-morbid conditions; Currently participating in an investigational drug or another device study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device success: Successful placement of a single device within the aortic annulus and; Acceptable hemodynamic performance (< 20 mmHg mean AV gradient or < 3.0 m/s peak velocity and < moderate-severe para-valvular AR assessed by echocardiography before discharge). Procedure safety: The composite of any death or disabling stroke at 30 days post-procedure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute procedural success: Device success and the absence of peri-procedural MACCE (including any death, disabling stroke, MI, repeat aortic valve intervention, major vascular complications, life threatening bleeding, or AKI- stage 3) before discharge. ;30 day major adverse events (MAE): Any of the following adverse events: any death, disabling stroke, MI, repeat aortic valve intervention, or AKI (Stage 3) at 30 days.;6 month MAE: Any of the following adverse events: any death, disabling stroke, MI, repeat aortic valve intervention, or AKI (Stage 3) at 6 months.;1 year MAE: Any of the following adverse events: any death, disabling stroke, MI, repeat aortic valve intervention, or AKI (Stage 3) at 1 year.;Survival: Freedom from any death at 1 year and annually up to 5 years.;Symptom improvement: Reduction in symptoms from baseline per New York Heart Association (NYHA) functional classification at 30 days, 6 months and 1 year.;Hemodynamic valve performance: Mean pressure gradient, peak velocity, aortic valve area (and index), and aortic regurgitation assessed by echocardiography pre-discharge at 30 days, 6 months, 1 year and annually for 5 years. | — |
Countries
Australia, Brazil
Contacts
Public ContactJuliana;Veronique de Castro;Jasner
Cardiovascular Research Center;Valve Medical Ltd
Outcome results
None listed