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

NCT05411055 | Active Not Recruiting

• 1 other identifier: MCH 2021-02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Aortic Valve Disease

Outcome Measures

Primary Outcomes (1)

• postoperative complications

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing aortic neocuspidal surgery

You may qualify if:

• severe aortic valve stenosis or insufficiency
• Written informed consent
• Willingness to carry out the follow-up visits

You may not qualify if:

• Other types of aortic valve surgery

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

MCH

Cotignola, Ravenna, 48033, Italy

Location

MeSH Terms

Conditions

Aortic Valve Disease

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 8, 2022
• Study Start: June 6, 2021
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2027
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

IT (1)