N/A
Completed N=140
Comparison of Two Pericardial Bioprostheses in AVR
Source: ClinicalTrials.gov NCT03796442 ↗Enrolled (actual)
140
Serious AEs
7.9%
Results posted
Feb 2023
Primary outcomePrimary: Transvalvular Mean Pressure Gradient (mPG) — 14.1; 13.9 mmHg — p=0.0004
Summary
The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transvalvular Mean Pressure Gradient (mPG) |
14.1; 13.9 | 0.0004 sig |
| SECONDARY Effective Orifice Area (EOA) |
1.48; 1.53 | — |
| SECONDARY Number of Participants With Op Mortality |
0; 0 | — |
| SECONDARY Number of Participants With Op Morbidities |
21; 24; 6; 7; 4; 2 | — |
| SECONDARY Number of Participants With All-cause Mortality |
1; 6 | — |
| SECONDARY Number of Participants With Cardiac Death |
1; 2 | — |
| SECONDARY Number of Participants With Aortic Valve-related Events |
5; 6 | — |
Eligibility Criteria
Inclusion Criteria
- patients who are going to undergo aortic valve replacement with bioprosthesis
Exclusion Criteria
- heart failure with severe LV dysfunction (LV EF <30%)
- active infective endocarditis
- with other critical cardiovascular disease (e.g. acute aortic dissection)
- with other critical comorbities by which the expected life span is less than 1 year
- inadequate participant by the researcher's discretion
Data sourced from ClinicalTrials.gov (NCT03796442). 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.