Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01651052
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 21, 2018
Information provided by (Responsible Party):
Edwards Lifesciences

July 18, 2012
July 26, 2012
August 21, 2018
July 2011
July 2018   (Final data collection date for primary outcome measure)
Safety Endpoints [ Time Frame: Intraoperative, discharge, 3 months, and annual scheduled follow-up visits (5 Years) ]
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
Long term Performance: Clinically acceptable function (aortic regurgita-tion and stenosis by echocardiogram) [ Time Frame: 5 Years ]
Complete list of historical versions of study NCT01651052 on Archive Site
Performance Endpoints [ Time Frame: 5-Years (at each scheduled follow-up visit) ]
  • 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
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 ]
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
Not Provided
Not Provided
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
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.
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.
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Aortic Valve Disorder
  • Aortic Valve Insufficiency
  • Aortic Valve Stenosis
  • Heart Failure
  • Coronary Artery Disease
Procedure: Heart Valve Surgery
Implant of an aortic valve, Model 11000
Experimental: Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
Intervention: Procedure: Heart Valve Surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Principal Investigator: Jerzy Sadowski, MD John Paul II Hospital
Principal Investigator: Jacek Rozanski, MD The Cardinal Stefan Wyszyński Institute of Cardiology
Edwards Lifesciences
August 2018

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