NCT01675440

Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

Medtronic CoreValve® U.S. Expanded Use Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 782 (actual)
• Sponsor: Medtronic Cardiovascular · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the Medtronic CoreValve® System for the treatment of symptomatic severe aortic stenosis in subjects with significant comorbidities in whom the risk of surgical aortic valve replacement has a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days.

Detailed description

The primary objective of the study is to evaluate the safety and effectiveness of the Medtronic CoreValve® System (MCS) in a subset of subjects excluded from the U.S. Extreme Risk Pivotal Trial population due to one or more additional co-morbidities, as measured by a composite of all-cause death or major stroke at 12 months, in the treatment of symptomatic severe aortic stenosis in subjects necessitating aortic valve replacement. Subjects enrolled in this study have a predicted operative mortality or serious, irreversible morbidity risk of ≥50% at 30 days associated with surgical aortic valve replacement.

Conditions

• Severe Aortic Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-12-01
• Completion: 2025-04-08
• First posted: 2012-08-30
• Last updated: 2026-04-03

Locations

43 sites across 1 country: United States