Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance
Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance
Tajima Ai
Medtronic Japan
Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
+81-3-6776-0007
ai.tajima2@medtronic.com
Tajima Ai
Medtronic Japan
Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo
+81-3-6776-0007
ai.tajima2@medtronic.com
Not Recruiting
June. 01, 2023
June. 01, 2023
100
Observational
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.
none
No limit
No limit
Both
aortic stenosis
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
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 thereafter up to 5 years.
MACCE is defined as a composite of:
- all-cause death
- myocardial infarction (MI)
- all stroke, and
- reintervention
3) Major Adverse Events (MAE)
Major Adverse Events (MAE) at 30 days, 6 months, 1 year and annually thereafter up to 5 years. MAE is defined as a composite of:
- 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
Conduction disturbance requiring permanent pacemaker implantation at 30 days, 6 months, 1 year and annually thereafter up to 5 years.
5) Change in NYHA class from baseline
Change in NYHA class from baseline at 30 days, 6 months, 1year and annually thereafter up to 5 years.
6) Echocardiographic assessment of valve performance
Echocardiographic assessment of valve performance at 30 days, 6 months, 12 months and annually thereafter up to 5 years using the following measures:
- transvalvular mean gradient
- effective orifice area (EOA)
- degree of aortic valve regurgitation (transvalvular and paravalvular)
7) Cardiovascular deaths and valve-related deaths
Cardiovascular deaths and valve-related deaths at 30 days, 6 months, 1 year and annually thereafter up to 5 years.
Cardiovascular death is defined as a composite of:
- 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 is defined as a composite of:
- 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
Strokes (of any severity) and TIAs at 30 days, 6 months, 1 year and annually thereafter up to 5 years.
9) Device success
Device success defined as follows, which is assessed with Postoperative
information:
- Successful vascular access, delivery and deployment of the device, and successful retrieval of the delivery system,
- Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function),
- Intended performance of the prosthetic valve1 (aortic valve area >1.2 cm2 for 26, 29 and 34mm valves, >0.9 cm2 for 23 mm valve (by echocardiography using the continuity equation) and mean aortic valve gradient <20 mmHg or peak velocity <3 m/sec, without moderate or severe prosthetic valve AR) not applicable for TAV in SAV subjects
- Only one study valve implanted in the proper anatomical location
10) Procedural success
Procedural success, defined as device success and absence of in-hospital MACCE.
