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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03677804

Enrollment

Registered

2018-09-19

Start date

2017-08-02

Completion date

2019-06-12

Last updated

2019-06-13

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

Conditions

Aortic Valve Disease

Keywords

aortic valve reconstruction, OZAKI technique, autologous pericardium

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion criteria

* missing informed consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
occurence of death	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery	Change in clinical Parameter: death
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 stroke	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery	Change in clinical parameter: stroke

Countries

Switzerland

Outcome results