Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT01651052
Recruitment Status : Completed
First Posted : July 26, 2012
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: N/A
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
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 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. Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) [ Time Frame: Events occurring within 30 days of procedure ]
    Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100

  2. Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) [ Time Frame: Events occurring >= 31 days and up through 5 years post-implant ]
    Number of late events divided by the total number of late patient years x 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).


Secondary Outcome Measures :
  1. Subject's Average Mean Gradient Measurements [ Time Frame: Baseline through 5-Year (at each scheduled follow-up visit) ]
    Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

  2. Subject's Average Effective Orifice Area Measurements [ Time Frame: Baseline through 5-Year (at each scheduled follow-up visit) ]
    Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

  3. Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. [ Time Frame: 3-6 Months and 1 through 5 Years compared to baseline ]

    The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life.

    Class I. Patients with cardiac disease but without resulting limitation of physical activity.

    Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest.

    Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest.

    Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.

    Symptoms of heart failure or the anginal syndrome may be present even at rest.


  4. Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey [ Time Frame: Baseline and one year follow-up ]

    The Medical Outcomes Study Short-Form 12 (SF-12) contains two components - the Physical Component Summary (PCS) and the Mental Component Summary (MCS).

    The SF-12 Physical Component Summary questionnaire scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.

    The SF-12 Mental Component Summary scale ranges from a maximum of 100, which reflects the best health status to a minimum of 0, which reflects the worst health status.


  5. Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time [ Time Frame: Baseline and 1 Year ]
    The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.


Other Outcome Measures:
  1. Subject's Average White Blood Cell Count [ Time Frame: Baseline, 3-6 Months, and 1 through 5 Years ]
    Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.

  2. Subject's Average Red Blood Cells Count [ Time Frame: Baseline, 3-6 Months, and 1 through 5 Years ]
    Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.

  3. Subject's Average Hemoglobin Count [ Time Frame: Baseline, 3-6 months, and 1 through 5 years ]
    Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.

  4. Subject's Average Hematocrit Percentage [ Time Frame: Baseline, 3-6 Months, and 1 through 5 Years ]
    Laboratory Analysis of Hematocrit Percentage on blood drawn from subjects. Hematocrit is the proportion of red blood cells to the fluid component(plasma) in the blood.

  5. Subject's Average Platelet Count [ Time Frame: Baseline, 3-6 Months, and 1 through 5 Years ]
    Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.

  6. Subject's Average Plasma Free Hemoglobin [ Time Frame: Baseline, 3-6 Months, and 1 through 5 Years ]
    Laboratory Analysis of Plasma Free Hemoglobin on blood drawn from subjects. This blood test measures the level of free hemoglobin in the liquid part of the blood (the serum).

  7. Subject's Average Serum Creatinine [ Time Frame: Baseline ]
    Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.

  8. Subject's Average International Normalized Ratio [ Time Frame: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years ]

    Laboratory Analysis of International Normalized Ratio (INR) on blood drawn from subjects.

    The INR is a calculation based on results of a prothrombin time (PT). The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.


  9. Subject's Average Partial Thromboplastin Time [ Time Frame: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years ]
    Laboratory Analysis of partial thromboplastin time (PTT) on blood drawn from subjects. PTT is a blood test that looks at how long it takes for the blood to clot.

  10. Subject's Average Prothrombin Time [ Time Frame: Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years ]
    Laboratory Analysis of Prothrombin Time (PT) on blood drawn from subjects. The PT is a blood test that measures the time it takes for the liquid portion (plasma) of the blood to clot.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Jerzy Sadowski, MD John Paul II Hospital
Principal Investigator: Jacek Rozanski, MD The Cardinal Stefan Wyszyński Institute of Cardiology
  Study Documents (Full-Text)

Documents provided by Edwards Lifesciences:
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01651052    
Other Study ID Numbers: 2010-03
First Posted: July 26, 2012    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: July 2019
Keywords provided by Edwards Lifesciences:
Aortic valve replacement/regurgitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Aortic Valve Stenosis
Aortic Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Coronary Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction