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

NCT ID: NCT03677804

Last Updated: 2019-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-02

Study Completion Date

2019-06-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* aortic valve reconstruction using autologous Pericardium (OZAKI technique)

Exclusion Criteria

* missing informed consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oliver Reuthebuch, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Herzchirurgie University Hospital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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Koechlin L, Schurr U, Miazza J, Imhof S, Maurer M, Erb J, Gahl B, Santer D, Berdajs D, Eckstein FS, Reuthebuch O. Echocardiographic and Clinical Follow-up After Aortic Valve Neocuspidization Using Autologous Pericardium. World J Surg. 2020 Sep;44(9):3175-3181. doi: 10.1007/s00268-020-05588-x.

Reference Type DERIVED
PMID: 32458022 (View on PubMed)

Other Identifiers

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2017-00556; ch17Reuthebuch

Identifier Type: -

Identifier Source: org_study_id

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