NCT03258333

Small Aortic Annulus - a New Solution to the Old Problem

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: The Federal Centre of Cardiovascular Surgery, Russia · Academic / Other
• Sex: All
• Age: 60 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Aortic Valve Replacement

Interventions

Type	Name	Description
PROCEDURE	aortic valve replacement	Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium

Timeline

• Start date: 2017-02-18
• Primary completion: 2022-01-01
• Completion: 2022-07-01
• First posted: 2017-08-23
• Last updated: 2017-08-23

Locations

1 site across 1 country: Russia