NCT01051518

Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)

Clinical Evaluation of Percutaneous Implantation of the CoreValve Aortic Valve Prosthesis. Safety and Performance Study on Patients at High Risk for Surgical Valve Replacement (18Fr Safety and Efficacy Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system. Approximately 120 patients presenting with symptomatic aortic native valve stenosis necessitating valve replacement which are considered poor surgical candidates, with a high surgical risk, as attested to by both the surgeon and the cardiologist are recruited in the study. Safety and performance will be evaluated at discharge and at 30 days post-procedure. Valve performance and placement will be followed up at 3 and 6 months post-procedure. Further long-term patient follow-up visits will be performed at 12, 24, 36 and 48 months post-procedure.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Medtronic CoreValve System	Transcatheter Aortic Valve

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-02-01
• Completion: 2013-06-01
• First posted: 2010-01-18
• Last updated: 2019-02-19
• Results posted: 2019-02-19

Locations

9 sites across 4 countries: Canada, Germany, Netherlands, United Kingdom