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Completed

NCT Number: NCT03677804

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

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.

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Key information

Conditions

Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Herzchirurgie University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion criteria

  • missing informed consent

Treatment and study plan

Primary outcomes

  1. Change in aortic transvalvular gradient measured by transthoracic echocardiography

    Time frame: 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 outcomes

  1. occurence of death

    Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

    Change in clinical Parameter: death

  2. occurence of cardiac re-surgery

    Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

    Change in clinical parameter: cardiac re-surgery

  3. occurence of stroke

    Time frame: From Baseline (end of cardiac surgery) until 12 months after cardiac surgery

    Change in clinical parameter: stroke

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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