Ross Operation Failure Database (ROFDA)

Database on Ross Operation Failures and Outcomes

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.

Study Overview

• Status: Withdrawn
• Conditions: Ross Operation; Pulmonary Autograft; Structural Valve Degeneration
• Intervention / Treatment: Procedure: Ross Operation

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 Type: Observational

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Centre Cardiologique du Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergone (or undergoing) to Ross Operation

Description

Inclusion Criteria:

• Patients undergone (or undergoing) to Ross Operation

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ross Operation; Patients undergone Ross Operation. Patients requiring reoperation	Procedure: Ross Operation; Replacement of the aortic valve by means of pulmonary artery autograft

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative complications	Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure	postoperative period (1-30 days)

Collaborators and Investigators

• Sponsor: Centre Cardiologique du Nord
• Collaborators: Ospedale San Donato; University of Bern; Groupe Hospitalier Pitie-Salpetriere; Royal Children's Hospital; Golden Jubilee National Hospital; Pontifícia Universidade Católica do Paraná
• Investigators: Principal Investigator: Francesco Nappi, MD, Centre Cardiologique du Nord

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2018
• Primary Completion (Estimated): January 1, 2019
• Study Completion (Estimated): March 1, 2019

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimated): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CN-17-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED