ClinicalTrials.Veeva

Menu

Ross Operation Failure Database (ROFDA)

C

Centre Cardiologique du Nord

Status

Withdrawn

Conditions

Structural Valve Degeneration
Pulmonary Autograft
Ross Operation

Treatments

Procedure: Ross Operation

Study type

Observational

Funder types

Other

Identifiers

NCT03027804
CN-17-001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 day to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergone (or undergoing) to Ross Operation

Exclusion criteria

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

Trial design

0 participants in 1 patient group

Ross Operation
Description:
Patients undergone Ross Operation. Patients requiring reoperation
Treatment:
Procedure: Ross Operation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems