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

Aortic Valve Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677804
• Other study ID #: 2017-00556; ch17Reuthebuch
• Status: Completed
• Start date: August 2, 2017
• Est. completion date: June 12, 2019

Study information

• Verified date: June 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 12, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion Criteria:

• missing informed consent

Related Conditions & MeSH terms

• Aortic Valve Disease

Locations

Country	Name	City	State
Switzerland	Herzchirurgie University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in aortic transvalvular gradient measured by transthoracic echocardiography	Change in aortic transvalvular gradient ( to analyze aortic valve stenosis or insufficiency) measured by transthoracic echocardiography	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Secondary	occurence of death	Change in clinical Parameter: death	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Secondary	occurence of cardiac re-surgery	Change in clinical parameter: cardiac re-surgery	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery
Secondary	occurence of stroke	Change in clinical parameter: stroke	From Baseline (end of cardiac surgery) until 12 months after cardiac surgery