N/A
Completed N=133
Clinical Trial of the Edwards Aortic Bioprosthesis, Model 11000
Aortic Valve Disorder · Aortic Valve Insufficiency · Aortic Valve Stenosis · Heart Failure
Source: ClinicalTrials.gov NCT01651052 ↗
Enrolled (actual)
133
Serious AEs
55.6%
Results posted
Jul 2019
Primary outcomePrimary: Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) — 2.3; 0.8; 0.0; 0.0 percentage
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Early Adverse Events Divided by Number of Subjects (Expressed as a Percentage) |
2.3; 0.8; 0.0; 0.0; 2.3; 0.0 | — |
| PRIMARY Number of Late Adverse Events Divided by Late Patient Years (Expressed as a Percentage) |
3.2; 0.7; 0.2; 0.2; 0.4; 0.2 | — |
| SECONDARY Subject's Average Mean Gradient Measurements |
49.4; 12.3; 12.2; 13.9; 13.8; 14.3 | — |
| SECONDARY Subject's Average Effective Orifice Area Measurements |
1.0; 2.0; 1.8; 1.8; 1.6; 1.5 | — |
| SECONDARY Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline. |
89; 36; 3; 68; 48; 6 | — |
| SECONDARY Subject's Average Score at Baseline and 1 Year on the Quality of Life Survey |
42.5; 49; 50.2; 51.2 | — |
| SECONDARY Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time |
0.81; 0.87 | — |
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
Data sourced from ClinicalTrials.gov (NCT01651052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.