Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Coronary Artery Disease Clinical Trial

Official title:

Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01651052
• Other study ID #: 2010-03
• Status: Completed
• Phase: N/A
• Start date: July 2011
• Est. completion date: July 2018

Study information

• Verified date: July 2019
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Disorder
• Aortic Valve Insufficiency
• Aortic Valve Stenosis
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

Procedure:
• Heart Valve Surgery
Implant of an aortic valve, Model 11000

Locations

Country	Name	City	State
Poland	Krakowski Szpital Specjalistyczny im. Jana Pawla II	Kraków
Poland	Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Bartus K, Litwinowicz R, Kusmierczyk M, Bilewska A, Bochenek M, Stapór M, Wozniak S, Rózanski J, Sadowski J, Kapelak B. Primary safety and effectiveness feasibility study after surgical aortic valve replacement with a new generation bioprosthesis: one-yea — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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

External Links

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