NCT01171625

Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis, Model 3300TFX

Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis in the Aortic Position, Model 3300TFX

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Edwards Lifesciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate the long term safety and effectiveness of the Carpentier-Edwards PERIMOUNT Magna Ease Valves in patients undergoing aortic valve replacement with or without concomitant procedures requiring cardiopulmonary bypass.

Detailed description

This is a prospective, single-arm, multi-center, interventional study to be conducted in the US and outside the US (OUS). This study will enroll a minimum of 225 patients implanted with the study valve in order to achieve 101 aortic valve replacement subjects each followed for a minimum of 8 years. The study will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged or malfunctioning natural or prosthetic aortic valve. Patients will be followed and assessed after implant at discharge, 6 months, one year, and annually for a minimum of 8 years.

Conditions

• Coronary Artery Disease
• Aortic Valve Disorder
• Heart Failure
• Aortic Valve Stenosis
• Aortic Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Implantation of CEP Magna Ease Model 3300TFX	Heart Valve Surgery

Timeline

• Start date: 2007-10-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2010-07-28
• Last updated: 2020-04-17
• Results posted: 2020-04-17

Locations

13 sites across 6 countries: United States, Austria, Canada, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated device study