Small Aortic Annulus - a New Solution to the Old Problem

• Conditions: Aortic Valve Replacement

• Registration Number: NCT03258333
• Lead Sponsor: The Federal Centre of Cardiovascular Surgery, Russia

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)

Study Timeline

• Study Start: 2017-02-18
• Study First Submitted: 2017-07-23
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-20
• Last Update Submitted: 2017-08-20
• Study First Posted: 2017-08-23
• Last Update Posted: 2017-08-23
• Primary Completion: 2022-01-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• severe degenerative aortic valve stenosis

Exclusion Criteria

• redo operation, infective endocarditis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Indexed effective orifice area, cm²/m²	12 months after surgery	Assessment of aortic valve dimension

Secondary Outcome Measures

Name	Time	Method
prosthesis-patient mismatch (PPM)	12 months after surgery	Indicator of the effectiveness of aortic valve replacement
Peak pressure gradient, mm.Hg	12 months after surgery	Indicator of the effectiveness of aortic valve replacement
Mean pressure gradient, mm.Hg	12 months after surgery	Indicator of the effectiveness of aortic valve replacement
Effective orifice area, EOA, cm²	12 months after surgery	Assessment of aortic valve dimension

Trial Locations

Locations (1)

FederalCCS; 🇷🇺 Penza, Russian Federation