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

Sponsor
Maria Cecilia Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05411055
Collaborator
(none)
60
Enrollment
1
Location
72
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium
    Actual Study Start Date :
    Jun 6, 2021
    Anticipated Primary Completion Date :
    Jun 6, 2026
    Anticipated Study Completion Date :
    Jun 6, 2027

    Outcome Measures

    Primary Outcome Measures

    1. postoperative complications [5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MCH Cotignola Ravenna Italy 48033

    Sponsors and Collaborators

    • Maria Cecilia Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Maria Cecilia Hospital
    ClinicalTrials.gov Identifier:
    NCT05411055
    Other Study ID Numbers:
    • MCH 2021-02
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Aortic Valve Disease

    Study Results

    No Results Posted as of Jun 8, 2022