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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Heart Failure; Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Disorder
• Intervention / Treatment: Procedure: Heart Valve Surgery

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
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawła II
  • Warsaw, Poland, 04-628
    • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Events occurring within 30 days of procedure
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).	Events occurring >= 31 days and up through 5 years post-implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through 5-Year (at each scheduled follow-up visit)
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.	Baseline through 5-Year (at each scheduled follow-up visit)
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.	3-6 Months and 1 through 5 Years compared to baseline
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.	Baseline and one year follow-up
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.	Baseline and 1 Year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject's Average White Blood Cell Count	Laboratory analysis of White Blood Cell Count on blood drawn from subject; WBC fight infection.	Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Red Blood Cells Count	Laboratory Analysis of Red Blood Cell Count on blood drawn from subjects; RBC carry oxygen.	Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Hemoglobin Count	Laboratory Analysis of Hemoglobin Count on blood drawn from subjects. Hemoglobin is an oxygen-carrying protein in red blood cells.	Baseline, 3-6 months, and 1 through 5 years
Subject's Average Hematocrit Percentage	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.	Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Platelet Count	Laboratory Analysis of Platelet Count on blood drawn from subjects; platelets help with blood clotting.	Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Plasma Free Hemoglobin	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).	Baseline, 3-6 Months, and 1 through 5 Years
Subject's Average Serum Creatinine	Laboratory Analysis of Serum Creatinine on blood drawn from subjects. Creatinine blood test is a test that measures kidney function.	Baseline
Subject's Average International Normalized Ratio	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.	Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Subject's Average Partial Thromboplastin Time	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.	Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years
Subject's Average Prothrombin Time	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.	Baseline, Discharge, 3-6 Months, 1 Year, 3 Years, and 5 Years

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Jerzy Sadowski, MD, John Paul II Hospital; Principal Investigator: Jacek Rozanski, MD, The Cardinal Stefan Wyszynski Institute of Cardiology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• EuroQol Standardized Instrument (EQ-5D) developed to measure of health-related quality of life
• Short Form Health Survey (SF-12) with 12 questions to measure functional health and well-being of patient's quality of life

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: July 18, 2012
• First Submitted That Met QC Criteria: July 24, 2012
• First Posted (Estimate): July 26, 2012

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Aortic valve replacement/regurgitation
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis; Aortic Valve Insufficiency; Aortic Valve Disease
• Other Study ID Numbers: 2010-03