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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

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ClinicalTrials.gov Identifier: NCT01651052
Recruitment Status : Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disorder Aortic Valve Insufficiency Aortic Valve Stenosis Heart Failure Coronary Artery Disease Procedure: Heart Valve Surgery Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Study Start Date : July 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aortic Bioprosthesis, Model 11000
Aortic valve replacement therapy
Procedure: Heart Valve Surgery
Implant of an aortic valve, Model 11000




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651052


Locations
Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Kraków, Poland, 31-202
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Warsaw, Poland, 04-628
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Principal Investigator: Jerzy Sadowski, MD John Paul II Hospital
Principal Investigator: Jacek Rozanski, MD The Cardinal Stefan Wyszyński Institute of Cardiology

Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01651052     History of Changes
Other Study ID Numbers: 2010-03
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Edwards Lifesciences:
Aortic valve replacement/regurgitation

Additional relevant MeSH terms:
Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction