Clinical trial NCT03027804: Ross Operation Failure Database
Official title: Database on Ross Operation Failures and Outcomes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ross Operation
Pulmonary Autograft
Structural Valve Degeneration
Lead sponsor: Centre Cardiologique du Nord
Sponsor class: OTHER
Collaborators: name: Golden Jubilee National Hospital
name: University of Bern
name: Pontifícia Universidade Católica do Paraná
name: Ospedale San Donato
name: Groupe Hospitalier Pitie-Salpetriere
name: Royal Children's Hospital
First posted: 2017-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergone (or undergoing) to Ross Operation

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergone (or undergoing) to Ross Operation

Exclusion Criteria:

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

Primary outcomes:
measure: Survival
timeFrame: from inclusion to 20 years follow-up
measure: Cardiac Death
timeFrame: from inclusion to 20 years follow-up
measure: Reoperation for Pulmonary Autograft Failure
timeFrame: from inclusion to 20 years follow-up
measure: Stroke
timeFrame: from inclusion to 20 years follow-up
measure: Rehospitalization for heart failure
timeFrame: from inclusion to 20 years follow-up
measure: Quality of life-1
timeFrame: from inclusion to 20 years follow-up
measure: Quality of life-2
timeFrame: from inclusion to 20 years follow-up
measure: Quality of life-3
timeFrame: from inclusion to 20 years follow-up
Secondary outcomes:
measure: Postoperative complications
timeFrame: postoperative period (1-30 days)
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Cardiologique Du Nord
Study officials:
affiliation: Centre Cardiologique du Nord
name: Francesco Nappi, MD
role: PRINCIPAL_INVESTIGATOR
References: