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Small Aortic Annulus - a New Solution to the Old Problem

Small Aortic Annulus - a New Solution to the Old Problem

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03258333
Enrollment
60
Registered
2017-08-23
Start date
2017-02-18
Completion date
2022-07-01
Last updated
2017-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Replacement

Keywords

aortic stenosis, aortic valve replacement, pericardium

Brief summary

In this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (\<21 mm) who underwent standard AVR with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (Ozaki procedure) (group 2, n=30)

Detailed description

Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging problem. Implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. Patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. The purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus (\<21 mm)

Interventions

PROCEDUREaortic valve replacement

Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium

Sponsors

The Federal Centre of Cardiovascular Surgery, Russia
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* severe degenerative aortic valve stenosis

Exclusion criteria

* redo operation, infective endocarditis

Design outcomes

Primary

MeasureTime frameDescription
Indexed effective orifice area, cm²/m²12 months after surgeryAssessment of aortic valve dimension

Secondary

MeasureTime frameDescription
prosthesis-patient mismatch (PPM)12 months after surgeryIndicator of the effectiveness of aortic valve replacement
Peak pressure gradient, mm.Hg12 months after surgeryIndicator of the effectiveness of aortic valve replacement
Mean pressure gradient, mm.Hg12 months after surgeryIndicator of the effectiveness of aortic valve replacement
Effective orifice area, EOA, cm²12 months after surgeryAssessment of aortic valve dimension

Other

MeasureTime frameDescription
Myocardial mass index, g/m²12 months after surgeryAssessment of reverse remodeling of the left ventricle
Indexed aortic annulus diameter, mm/m²12 months after surgeryDescription and comparison of groups patients
Age (years)12 months after surgeryDescription and comparison of groups patients
Body mass index, kg/m²12 months after surgeryDescription and comparison of groups patients
Body surface area, m²12 months after surgeryDescription and comparison of groups patients
Aortic annulus diameter, mm12 months after surgeryDescription and comparison of groups patients

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026