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Completed

NCT Number: NCT01651052

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.

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Key information

Conditions

Aortic Valve Disorder Aortic Valve Disease Aortic Valve Insufficiency Aortic Valve Stenosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Failure Heart Valve Diseases Myocardial Ischemia Vascular Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krakowski Szpital Specjalistyczny im. Jana Pawła II, Krakow, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart valve surgery

Procedure

Implant of an aortic valve, Model 11000

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2012
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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