Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Valve Disorder
- Sponsor
- Edwards Lifesciences
- Enrollment
- 133
- Locations
- 2
- Primary Endpoint
- Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage)
Time Frame: 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)
Time Frame: 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 Outcomes
- Subject's Average Effective Orifice Area Measurements(Baseline through 5-Year (at each scheduled follow-up visit))
- Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline.(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(Baseline and one year follow-up)
- Subject's Average Mean Gradient Measurements(Baseline through 5-Year (at each scheduled follow-up visit))
- Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time(Baseline and 1 Year)