Clinical outcomess of Evolut-in-SAPIEN in Japan

JRCT ID: jRCT1052230036

Registered date:12/06/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: structural valve deterioration
• Date of first enrollment: 12/06/2023
• Target sample size: 16
• Study type: Observational

Outcome(s)

• Primary Outcome: 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 Outcome: All-cause mortality, all-cause stroke, and procedure- or prosthetic valve-related hospitalization at 1 year postoperatively

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 16 cases of TAV-in-TAV performed at our hospital (10 Evolut-in-SAPIEN, 5 SAPIEN-in-SAPIEN, 1 Evolut-in-CoreValve)
• Exclude criteria: TAV-in-TAV for intraoperative bail-out

Related Information

• Primary Sponsor: Maeda Koichi
• Source(s) of Monetary Support: Medtronic Japan, Co., Ltd.