NCT06924151

Isolated Surgical Aortic Valve Replacement in Low Risk AS Patients

the Prospective, Randomized, Controlled, Multi-center Study to Establish the Safety and Effectiveness of Isolated Surgical Aortic Valve Replacement in Low Risk Patients Who Have Symptomatic Severe Aortic Stenosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: Osaka University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To establish the safety and effectiveness of surgical aortic valve replacement (SAVR) in patients with isolated severe, calcific aortic stenosis who are at low surgical risk.

Detailed description

This study is the Prospective, Randomized, Controlled, Multi-center Study of Isolated SAVR in Low Risk AS Patients (The AMETHYST trial). Patients will be randomized 1:1 to receive either SAVR or transcatheter heart valve replacement (TAVR) with a commercially available surgical and transcatheter bioprosthetic valves. The aim of this study was to assess the non-inferiority of SAVR compared with TAVR for the combined endpoints of death from any cause, stroke and rehospitalization (hospitalization related to biological valves or procedures or heart failure) at 1 year postoperatively. Patients will be seen for follow-up visits at discharge, 30 days, and annually through 10 years.

Conditions

• Aortic Stenosis

Interventions

Type	Name	Description
PROCEDURE	surgical aortic valve replacement	SAVR
PROCEDURE	Transcatheter aortic valve replacement	TAVR

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-05-31
• Completion: 2037-05-31
• First posted: 2025-04-11
• Last updated: 2025-08-28

Locations

37 sites across 1 country: Japan