Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aortic Bioprosthesis, Model 11000

Aortic valve replacement therapy

Group Type EXPERIMENTAL

Heart Valve Surgery

Intervention Type PROCEDURE

Implant of an aortic valve, Model 11000

Interventions

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Heart Valve Surgery

Implant of an aortic valve, Model 11000

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No