CoreValve Evolut R TAV in SAV Japan Regulatory PMS

CoreValve Evolut R TAV in SAV Japan Regulatory PMS - TAV in SAV Japan Reg PMS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033216

Enrollment

300

Registered

2018-06-30

Start date

2018-09-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic valve disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with symptomatic valvular heart disease caused by the insufficiency (stenosed, closure, 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. However, chronic dialysis patients are excluded.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
Hemodynamics	—

Secondary

Measure	Time frame
1. Procedural success 2. Incidence of all-cause death 3. Incidence of serious stroke 4. Incidence of MACCE 5. Incidence of serious vascular complications 6. New placement of implanted heart pacemaker 7. Vessel access route 8. Conducting post-dilation of balloon catheter 9. Information related to antiplatelet therapy 10. Presence or absence of multiple valve use at the time of placement	—

Countries

Japan

Contacts

Public ContactMoe Terauchi

Medtronic Japan Co.,Ltd. Clinical Research and Medical Science, Evidence Solution

moe.terauchi@medtronic.com03-6776-0007

Outcome results