Ross Operation Failure Database

NCT ID: NCT03027804

Last Updated: 2023-06-07

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-03-01

Brief Summary

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A large multicentric registry to obtain data to analyse the pulmonary autograft (PA) failure phenomenon and feed more complex biomechanical models to be integrated with clinical imaging with the final aim to predict Ross operation's outcomes and define strategies to ameliorate its results.

Detailed Description

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On the basis of the current knowledge on the outcomes of Ross Operation we aim to create a large multi centric registry in order to obtain data on the preoperative intraoperative management of these patients and on the postoperative long-term results of this procedure.

Patients data will be entered by the investigators in an electronic database Preoperative variables will include age, comorbidities, functional status, indications for surgery, morphology of the aortic valve Additional morphological data and aortic and pulmonary measurements will be taken intraoperatively Postoperative follow-up data including both clinical outcomes (mortality, reoperation for pulmonary autograft failure, major cardiac events, stroke, infection) and morphological measurements by means of CT scan or echocardiography, will be inserted.

Quality of life by means of SF12 and Minnesota living with heart failure questionnaire and EQ-5D score will be collected.

Follow-up endpoints are at discharge, 1 year 5 years 10 years 15 years and 20 years.

Conditions

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Ross Operation Pulmonary Autograft Structural Valve Degeneration

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Ross Operation

Patients undergone Ross Operation. Patients requiring reoperation

Ross Operation

Intervention Type PROCEDURE

Replacement of the aortic valve by means of pulmonary artery autograft

Interventions

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Ross Operation

Replacement of the aortic valve by means of pulmonary artery autograft

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients undergone (or undergoing) to Ross Operation

Exclusion Criteria

* Patients requiring combined cardiac surgical procedure in association to Ross Operation
Minimum Eligible Age

1 Day

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role collaborator

University of Bern

OTHER

Sponsor Role collaborator

Pontifícia Universidade Católica do Paraná

OTHER

Sponsor Role collaborator

Ospedale San Donato

OTHER

Sponsor Role collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

Sponsor Role collaborator

Royal Children's Hospital

OTHER

Sponsor Role collaborator

Centre Cardiologique du Nord

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Nappi, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Cardiologique du Nord

Locations

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Centre Cardiologique Du Nord

Paris, , France

Site Status

Countries

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France

Other Identifiers

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CN-17-001

Identifier Type: -

Identifier Source: org_study_id

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