Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium (Ozaki Procedure)

Aortic Valve Disease Clinical Trial

— PARACADUTE  

Official title:

Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05411055
• Other study ID #: MCH 2021-02
• Status: Active, not recruiting
• Start date: June 6, 2021
• Est. completion date: June 6, 2027

Study information

• Verified date: June 2023
• Source: Maria Cecilia Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Ozaki aortic valve reconstruction procedure uses autologous or bovine pericardium as an aortic cusp replacement without the use of struts and with use of the patient's own native aortic root. In this technique one can replace individual aortic cusps, 1, 2, or all 3 cusps. Ideally the patient's autologous pericardium will be harvested and fixed in gluteraldehyde at the time and prepared for the patient's specific annular dimensions with the neoaortic root sizers. Based on the measured size, one then uses a leaflet template to independently replace the cusps resulting in more effective preservation of the natural motion of the aortic valve annulus in coordination of the left ventricle, aortic annulus, sinus of Valsalva, and aorta compared to stented bioprosthetic and/or mechanical aortic valve replacements. Professor Ozaki has now performed 1000 Ozaki neoaortic valve reconstructive operations and has better than 95% freedom from re-operation at late follow-up. The objective of this study is to collect a large collection of prospective data from patients undergoing aortic neocuspidalization surgery for aortic valve insufficiency or stenosis isolated or combined with other procedures

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 6, 2027
• Est. primary completion date: June 6, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe aortic valve stenosis or insufficiency

• Written informed consent

• Willingness to carry out the follow-up visits

Exclusion Criteria:

• Other types of aortic valve surgery

Related Conditions & MeSH terms

• Aortic Valve Disease

Locations

Country	Name	City	State
Italy	MCH	Cotignola	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
Maria Cecilia Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative complications		5 years