Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000

Edwards Lifesciences133 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Aortic Valve Disorder Aortic Valve Insufficiency Aortic Valve Stenosis Heart Failure Coronary Artery Disease

Interventions

Heart Valve SurgeryPROCEDURE

Implant of an aortic valve, Model 11000

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Krakowski Szpital Specjalistyczny im. Jana Pawła II

Krakow, Poland

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Warsaw, Poland

Outcomes

Primary Outcomes

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

Time frame: 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).

Time frame: Events occurring >= 31 days and up through 5 years post-implant

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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