Aortic Valve Reconstruction Using Autologous Pericardium: Single Center Experience With the Ozaki Technique

Completed

• Conditions: Aortic Valve Disease

• Registration Number: NCT03677804
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure (Aortic valve reconstruction using autologous pericardial tissue) at the department of cardiac surgery/ University Hospital Basel/ Switzerland.

Detailed Description

The reconstruction of the aortic valve using autologous pericardium, applying the technique Ozaki et al., published first in 2011 provides potential benefits due to the missing necessity of oral anticoagulation and its use in patients with small aortic annuli, because of the huge orifice area. There is a need of more data to evaluate the significance of this technique in the treatment of aortic valve stenosis and regurgitation. The department of cardiac surgery/ University Hospital Basel/ Switzerland started to use this technique in September 2015. The aim of this study is to analyse the short-term results of the first patients undergoing the OZAKI procedure.

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-19
• Primary Completion: 2019-05-01
• Status Verified: 2019-06
• Study Completion: 2019-06-12
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion Criteria

• missing informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in aortic transvalvular gradient measured by transthoracic echocardiography	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery	Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
occurence of stroke	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery	Change in clinical parameter: stroke
occurence of cardiac re-surgery	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery	Change in clinical parameter: cardiac re-surgery
occurence of death	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery	Change in clinical Parameter: death

Trial Locations

Locations (1)

Herzchirurgie University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland