NCT03027804

Ross Operation Failure Database

Database on Ross Operation Failures and Outcomes

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Centre Cardiologique du Nord · Academic / Other
• Sex: All
• Age: 1 Day – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ross Operation
• Pulmonary Autograft
• Structural Valve Degeneration

Interventions

Type	Name	Description
PROCEDURE	Ross Operation	Replacement of the aortic valve by means of pulmonary artery autograft

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-01-01
• Completion: 2019-03-01
• First posted: 2017-01-23
• Last updated: 2023-06-07

Locations

1 site across 1 country: France