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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences
ClinicalTrials.gov Identifier:
NCT01651052
First received: July 18, 2012
Last updated: October 4, 2013
Last verified: October 2013

July 18, 2012
October 4, 2013
July 2011
December 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) ] [ 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
Long term Performance: Clinically acceptable function (aortic regurgita-tion and stenosis by echocardiogram) [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01651052 on ClinicalTrials.gov Archive Site
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
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
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
December 2018
December 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01651052
2010-03
Yes
Edwards Lifesciences
Edwards Lifesciences
Not Provided
Study Director: Carol Renner Edwards Lifesciences
Edwards Lifesciences
October 2013

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