NCT01051310

Medtronic CoreValve REDO Study

Feasibility Study of Percutaneous Aortic Valve Implantation With the Medtronic CoreValve System for Percutaneous Aortic Valve Replacement (PAVR) in Patients With a Failing Previously Surgically Implanted Aortic Bioprosthesis and Presenting a High Risk for Repeat Surgical Valve Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The proposed investigation is a prospective, multicenter, non-randomized study to evaluate the immediate benefits (at discharge and at 30 days) in terms of performance and safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis. In addition, the study aims to evaluate the performance and the safety of the implantation of the Medtronic CoreValve PAV in a failing aortic bioprosthesis at subsequent annual follow-ups out to 48 months post procedure. These objectives will be achieved through the following endpoints: * Primary safety endpoint - Composite of Major Adverse Events * Primary performance endpoint - Technical and procedural success at discharge Patient Population: Eligible subjects will be at least 75 years old, presenting with a failing aortic bioprosthesis (stenotic, incompetent or mixed) including homograft or stented or stentless heterograft, considered poor surgical candidates and necessitating repeat aortic valve replacement. Up to 20 patients will be included in up to four hospitals.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve System	Transcatheter Aortic Valve

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-01-01
• Completion: 2011-01-01
• First posted: 2010-01-18
• Last updated: 2019-01-31
• Results posted: 2019-01-31

Locations

3 sites across 2 countries: Germany, Netherlands