Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

This study is currently recruiting participants.

Verified November 2012 by Edwards Lifesciences

Sponsor:

Information provided by (Responsible Party):

Edwards Lifesciences

ClinicalTrials.gov Identifier:

NCT01651052

First received: July 18, 2012

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 18, 2012

Last Updated Date

November 27, 2012

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety Endpoints [ Time Frame: Intraoperative, discharge, 3 months, and annual scheduled follow-up visits (5 Years) ] [ Designated as safety issue: Yes ]

Descriptive information of early rates and late linearized rates of the follow-ing:

Structural valve deterioration
Thromboembolism
All bleeding/hemorrhage
Major bleeding/hemorrhage
All paravalvular leak
Major paravalvular leak
Non-structural valve dysfunction
Endocarditis
Hemolysis
All cause mortality
Trial valve-related mortality
Explant

Original Primary Outcome Measures ^ICMJE

Long term Performance: Clinically acceptable function (aortic regurgita-tion and stenosis by echocardiogram) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01651052 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Performance Endpoints [ Time Frame: 5-Years (at each scheduled follow-up visit) ] [ Designated as safety issue: No ]

Clinically acceptable hemodynamic performance confirmed by core lab evaluation of echocardiography
New York Heart Association (NYHA) functional class com-pared to baseline
Change in Quality of Life questionnaires EQ-5D (EuroQol) and Short Form 12 version 2 (SF-12v2) from baseline/screening to 1-year

Original Secondary Outcome Measures ^ICMJE

Clinically acceptable function (aortic regurgitation by echocardiogram). The safety outcomes that are considered valve-related along with hemodynamic performance and NYHA Classification. [ Time Frame: 5 Years ] [ Designated as safety issue: Yes ]

Safety outcome measures will include the following:

Index valve-related mortality
Thromboembolic events
Index valve thrombosis
Major anticoagulation-related bleeding events
Index valve paravalvular leakage
Index valve-related endocarditis
Index valve structural valve deterioration
Hemolysis
Index valve-related reoperation

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Official Title ^ICMJE

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Brief Summary

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.

Detailed 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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: Heart Valve Surgery

Implant of an aortic valve, Model 11000

Study Arm (s)

Experimental: Aortic Bioprosthesis, Model 11000

Aortic valve replacement therapy

Intervention: Procedure: Heart Valve Surgery

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2018

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Poland

Administrative Information

NCT Number ^ICMJE

NCT01651052

Other Study ID Numbers ^ICMJE

2010-03

Has Data Monitoring Committee

Yes

Responsible Party

Edwards Lifesciences

Study Sponsor ^ICMJE

Edwards Lifesciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Carol Renner

Edwards Lifesciences

Information Provided By

Edwards Lifesciences

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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