Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-01 @ 8:03 PM
Study NCT ID:
NCT03027804
Status:
WITHDRAWN
Last Update Posted:
2023-06-07
First Post:
2017-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ross Operation Failure Database
Sponsor:
Centre Cardiologique du Nord
Organization:
Study Overview
Official Title:
Database on Ross Operation Failures and Outcomes
Status:
WITHDRAWN
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study has been changed in systematic review and meta-analysis
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ROFDA
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: