Clinical outcomess of Evolut-in-SAPIEN in Japan

Safety and Efficacy of Evolut-in-SAPIEN in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1052230036

Enrollment

Registered

2023-06-12

Start date

2023-06-12

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

structural valve deterioration structural valve deterioration

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 16 cases of TAV-in-TAV performed at our hospital (10 Evolut-in-SAPIEN, 5 SAPIEN-in-SAPIEN, 1 Evolut-in-CoreValve)

Exclusion criteria

Exclusion criteria: TAV-in-TAV for intraoperative bail-out

Design outcomes

Primary

Measure	Time frame
All-cause mortality at 30 days, all strokes, major hemorrhage, major vascular complications, cardiac structural complications (coronary occlusion, annular rupture, cardiac tamponade), acute kidney injury, moderate or severe AR, new permanent pacemaker, composite endpoint of surgery or intervention on device)	—

Secondary

Measure	Time frame
All-cause mortality, all-cause stroke, and procedure- or prosthetic valve-related hospitalization at 1 year postoperatively	—

Contacts

Public ContactKoichi Maeda

Osaka University Graduate School of Medicine

k-maeda@surg1.med.osaka-u.ac.jp+81-6-6879-3154

Outcome results