aortic stenosis
Conditions
Interventions
None listed
Sponsors
Medtronic Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In the surveillance, chronic dialysis patients* who are used the product at the surveillance sites (PRO+model: 23 mm, 26 mm, 29 mm, 34 mm, FX model: 23 mm, 26 mm, 29 mm, 34 mm) are subjects to be surveyed. This product is a self-expanding percutaneous aortic valve system (porcine pericardium tissue valve) which used for the percutaneous heart valve replacement and indicated for the following patients. -Patients with severe symptomatic native aortic stenosis caused by the calcification of native aortic valve leaflets and whom are determined that the therapy using this product is the most suitable treatment. However, in the case of chronic dialysis patients, it is limited to those patients who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment. -Patients with valvular disease caused by failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve, and who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment. 34 mm size TAV is only for the native aortic.
Exclusion criteria
Exclusion criteria: N/A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)All-cause death or disabling stroke at 1 year 2)Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) event-free rates and the occurrence of individual MACCE components at 30 days, 6 months, 1year and annually up to 5 years -all-cause death -myocardial infarction (MI) -all stroke -reintervention 3)Major Adverse Events (MAE) at 30 days, 6 months, 1 year and annually up to 5 years -MACCE -Acute kidney Injury -Cardiac tamponade -Prosthetic valve dysfunction -Cardiogenic shock -Valve endocarditis -Life-threatening, disabling or major bleeding -Serious vascular complication -Cardiac perforation -Device migration/Valve embolism 4)Conduction disturbance requiring permanent pacemaker implantation at 30 days, 6 months, 1 year and annually up to 5 years 5)Change in NYHA class from baseline at 30 days, 6 months, 1year and annually up to 5 years 6)Echocardiographic assessment of valve performance at 30 days, 6 months, 12 months and annually up to 5 years -transvalvular mean gradient -effective orifice area (EOA) -degree of aortic valve regurgitation 7)Cardiovascular deaths and valve-related deaths at 30 days, 6 months, 1 year and annually up to 5 years Cardiovascular death: -Any death due to proximate cardiac cause (e.g. MI, cardiac tamponade, worsening heart failure) -All procedure-related deaths, including those related to a complication of the procedure or treatment for a complication of the procedure -Death caused by non-coronary vascular conditions such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular disease Valve-related death: -Any death caused by prosthetic valve dysfunction, valve thrombosis, embolism, bleeding event, or implanted valve endocarditis -Death related to reintervention on the operated valve. 8)Strokes (of any severity) and TIAs at 30 days, 6 months, 1 year and annually up to 5 years 9)Device success 10)Procedural success defined as device success | — |
Countries
Japan
Contacts
Public ContactAi Tajima
Medtronic Japan Clinical Research and Medical Science
Outcome results
None listed