Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Heart Failure; Aortic Valve Disorder; Aortic Valve Insufficiency; Coronary Artery Disease
• Interventions: Procedure: Heart Valve Surgery

• Registration Number: NCT01651052
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-24
• Study First Posted: 2012-07-26
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2019-04-22
• Status Verified: 2019-07
• Results First Submitted QC: 2019-07-24
• Last Update Submitted: 2019-07-24
• Results First Posted: 2019-07-26
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aortic Bioprosthesis, Model 11000	Heart Valve Surgery	Aortic valve replacement therapy

Primary Outcome Measures

Name	Time	Method
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)	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
Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage)	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

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

Trial Locations

Locations (2)

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; 🇵🇱 Warsaw, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawła II; 🇵🇱 Kraków, Poland