Ross Operation Failure Database

Withdrawn

• Conditions: Ross Operation; Structural Valve Degeneration; Pulmonary Autograft
• Interventions: Procedure: Ross Operation

• Registration Number: NCT03027804
• Lead Sponsor: Centre Cardiologique du Nord

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.

Study Timeline

• Study First Submitted: 2017-01-18
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Study Start: 2018-09-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergone (or undergoing) to Ross Operation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ross Operation	Ross Operation	Patients undergone Ross Operation. Patients requiring reoperation

Primary Outcome Measures

Name	Time	Method
Quality of life-3	from inclusion to 20 years follow-up	Quality of life as measured withEQ 5D score
Cardiac Death	from inclusion to 20 years follow-up	Mortality due to cardiac cause
Reoperation for Pulmonary Autograft Failure	from inclusion to 20 years follow-up	Need for reoperation due to failure of pulmonary autograft or valve degeneration
Quality of life-1	from inclusion to 20 years follow-up	Quality of life as measured with SF-12
Rehospitalization for heart failure	from inclusion to 20 years follow-up	Readmission to hospital for heart failure
Survival	from inclusion to 20 years follow-up	Death from any cause
Stroke	from inclusion to 20 years follow-up	neurological stroke with impairment
Quality of life-2	from inclusion to 20 years follow-up	Quality of life as measured with Minnesota living with heart failure questionnaire

Secondary Outcome Measures

Name	Time	Method
Postoperative complications	postoperative period (1-30 days)	Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure

Trial Locations

Locations (1)

Centre Cardiologique Du Nord; 🇫🇷 Paris, France