Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Edwards Lifesciences

Status: Completed

Conditions: Coronary Artery Disease; Aortic Valve Stenosis; Heart Failure; Aortic Valve Insufficiency; Aortic Valve Disorder

Treatments: Procedure: Heart Valve Surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651052

2010-03

Details and patient eligibility

About

The purpose of this observational trial is to gather further clinical data to confirm the safety and performance of the Edwards Pericardial Aortic Bioprosthesis, Model 11000 in this trial population.

Full description

This is a prospective, non-randomized, non-controlled observational clinical trial. Up to 200 subjects will be enrolled at up to 6 participating clinical sites. The trial will include male and female patients, 18 years or older, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic valve. Patients will be followed and assessed after implant for up to 5 years.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Require replacement of aortic valve
• Signed informed consent
• Willing to return to study site for follow-up visits

Exclusion criteria

• Active endocarditis/myocarditis (< 3 months)
• Myocardial infarction (< 30 days)
• Renal insufficiency/ End-stage renal disease
• Life expectancy (< 1 year)
• Requires multiple valve replacement/repair
• Requiring emergent aortic valve surgery
• Pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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133 participants in 1 patient group

Aortic Bioprosthesis, Model 11000

Experimental group

Description:

Aortic valve replacement therapy

Treatment:

Procedure: Heart Valve Surgery