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

Aortic Valve Neocuspidization With Glutaraldehyde-Treated Autologous Pericardium

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

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Disease

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Alberto Albertini, MD; Phone Number: +39 0545 217693; Email: aalbertini@gvmnet.it
• Study Contact Backup: Name: Elena Tenti, PharmD; Email: etenti@gvmnet.it

Study Locations

• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • MCH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing aortic neocuspidal surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative complications	5 years

Collaborators and Investigators

• Sponsor: Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2021
• Primary Completion (Estimated): June 6, 2026
• Study Completion (Estimated): June 6, 2027

Study Registration Dates

• First Submitted: June 6, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: MCH 2021-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No