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Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Primary Purpose

Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Heart Valve Surgery
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disorder focused on measuring Aortic valve replacement/regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Aortic Bioprosthesis, Model 11000

Arm Description

Aortic valve replacement therapy

Outcomes

Primary Outcome Measures

Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
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

Subject's Average Mean Gradient Measurements
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.
Subject's Average Effective Orifice Area Measurements
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.
Subject's New York Heart Association (NYHA) Functional Class 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.
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
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.
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
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.

Full Information

First Posted
July 18, 2012
Last Updated
July 24, 2019
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT01651052
Brief Title
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Official Title
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disorder, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Failure, Coronary Artery Disease
Keywords
Aortic valve replacement/regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aortic Bioprosthesis, Model 11000
Arm Type
Experimental
Arm Description
Aortic valve replacement therapy
Intervention Type
Procedure
Intervention Name(s)
Heart Valve Surgery
Intervention Description
Implant of an aortic valve, Model 11000
Primary Outcome Measure Information:
Title
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Description
Number of early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100
Time Frame
Events occurring within 30 days of procedure
Title
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)
Description
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).
Time Frame
Events occurring >= 31 days and up through 5 years post-implant
Secondary Outcome Measure Information:
Title
Subject's Average Mean Gradient Measurements
Description
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.
Time Frame
Baseline through 5-Year (at each scheduled follow-up visit)
Title
Subject's Average Effective Orifice Area Measurements
Description
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.
Time Frame
Baseline through 5-Year (at each scheduled follow-up visit)
Title
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.
Description
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.
Time Frame
3-6 Months and 1 through 5 Years compared to baseline
Title
Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey
Description
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.
Time Frame
Baseline and one year follow-up
Title
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time
Description
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.
Time Frame
Baseline and 1 Year
Other Pre-specified Outcome Measures:
Title
Subject's Average White Blood Cell Count
Description
Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.
Time Frame
Baseline, 3-6 Months, and 1 through 5 Years
Title
Subject's Average Red Blood Cells Count
Description
Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.
Time Frame
Baseline, 3-6 Months, and 1 through 5 Years
Title
Subject's Average Hemoglobin Count
Description
Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.
Time Frame
Baseline, 3-6 months, and 1 through 5 years
Title
Subject's Average Hematocrit Percentage
Description
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.
Time Frame
Baseline, 3-6 Months, and 1 through 5 Years
Title
Subject's Average Platelet Count
Description
Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.
Time Frame
Baseline, 3-6 Months, and 1 through 5 Years
Title
Subject's Average Plasma Free Hemoglobin
Description
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).
Time Frame
Baseline, 3-6 Months, and 1 through 5 Years
Title
Subject's Average Serum Creatinine
Description
Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.
Time Frame
Baseline
Title
Subject's Average International Normalized Ratio
Description
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.
Time Frame
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Title
Subject's Average Partial Thromboplastin Time
Description
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.
Time Frame
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Title
Subject's Average Prothrombin Time
Description
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.
Time Frame
Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerzy Sadowski, MD
Organizational Affiliation
John Paul II Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacek Rozanski, MD
Organizational Affiliation
The Cardinal Stefan Wyszyński Institute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krakowski Szpital Specjalistyczny im. Jana Pawła II
City
Kraków
ZIP/Postal Code
31-202
Country
Poland
Facility Name
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
City
Warsaw
ZIP/Postal Code
04-628
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26182627
Citation
De La Fuente AB, Wright GA, Olin JM, Duhay FG, Kapelak B, Bochenek M, Bartus K, Sadowski J. Advanced Integrity Preservation Technology Reduces Bioprosthesis Calcification While Preserving Performance and Safety. J Heart Valve Dis. 2015 Jan;24(1):101-9.
Results Reference
background
PubMed Identifier
29297188
Citation
Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapor M, Wozniak S, Rozanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-year outcomes. Kardiol Pol. 2018;76(3):618-624. doi: 10.5603/KP.a2017.0262. Epub 2018 Jan 3.
Results Reference
result
PubMed Identifier
25371311
Citation
Sadowski J, Bartus K, Kapelak B, Chung A, Stapor M, Bochenek M. Aortic valve replacement with a novel anti-calcification technology platform. Kardiol Pol. 2015;73(5):317-22. doi: 10.5603/KP.a2014.0214. Epub 2014 Nov 5.
Results Reference
result
PubMed Identifier
33141188
Citation
Bartus K, Litwinowicz R, Bilewska A, Stapor M, Bochenek M, Rozanski J, Sadowski J, Filip G, Kusmierczyk M, Kapelak B. Final 5-year outcomes following aortic valve replacement with a RESILIA tissue bioprosthesis. Eur J Cardiothorac Surg. 2021 Jan 29;59(2):434-441. doi: 10.1093/ejcts/ezaa311.
Results Reference
derived
Links:
URL
https://euroqol.org/eq-5d-instruments/
Description
EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life

Learn more about this trial

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

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