N/A N=140 Randomized Treatment

Comparison of Two Pericardial Bioprostheses in AVR

Aortic Valve Disease

Bottom Line

View on ClinicalTrials.gov: NCT03796442 ↗

Enrolled (actual)

140

Serious AEs

7.9%

Results posted

Feb 2023

Primary outcome: Primary: Transvalvular Mean Pressure Gradient (mPG) — 14.1; 13.9 mmHg — p=0.0004

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: AVR with AVALUS (Device); AVR with CEPME (Device)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Seoul National University Hospital
Primary completion: May 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.