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Database on Ross Operation Failures and Outcomes (NCT03027804)

University of Bern
Royal Children's Hospital
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.
  • Procedure: Ross Operation
    Replacement of the aortic valve by means of pulmonary artery autograft
    Ages eligible for Study
    up to 80 Years
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • Patients undergone (or undergoing) to Ross Operation
    Exclusion Criteria:
    • Patients requiring combined cardiac surgical procedure in association to Ross Operation
    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.

    1 locations

    France (1)
    • Centre Cardiologique Du Nord
      Not specified
      Paris, France
    Status:
    enrolling by invitation
    Type:
    Observational Patient Registry
    Phase:
    -
    Start:
    04 August, 2017
    Updated:
    18 July, 2017
    Participants:
    15000
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