NCT07120048

Real World Data Collection on the INSPIRIS RESILIA Aortic Valve

A Prospective, Observational Registry Study Designed to Collect Real-world Hemodynamic and Clinical Outcomes of the INSPIRIS RESILIA Aortic Valve

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Collect real-world data on hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A, in subjects requiring replacement of their native or prosthetic aortic valve as the only heart valve procedure during the index procedure, with or without other concomitant procedures.

Detailed description

Subjects in the INDICATE registry study will be enrolled at up to 20 sites in Germany. Up to 500 subjects will be implanted with the INSPIRIS RESILIA Aortic Valve in this registry.

Conditions

• Aortic Valve Disease

Interventions

Type	Name	Description
DEVICE	Edwards INSPIRIS RESILIA Aortic Valve	Surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve

Timeline

• Start date: 2025-07-30
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2025-08-13
• Last updated: 2026-04-02

Locations

11 sites across 1 country: Germany