Ross Operation Failure Database

Structural Valve Degeneration Clinical Trial

— ROFDA  

Official title:

Database on Ross Operation Failures and Outcomes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03027804
• Other study ID #: CN-17-001
• Status: Withdrawn
• Start date: September 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: June 2023
• Source: Centre Cardiologique du Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 80 Years

Eligibility

Inclusion Criteria:

• Patients undergone (or undergoing) to Ross Operation

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Pulmonary Autograft
• Ross Operation
• Structural Valve Degeneration

Intervention

Procedure:
• Ross Operation
Replacement of the aortic valve by means of pulmonary artery autograft

Locations

Country	Name	City	State
France	Centre Cardiologique Du Nord	Paris

Sponsors (7)

Lead Sponsor	Collaborator
Centre Cardiologique du Nord	Golden Jubilee National Hospital, Groupe Hospitalier Pitie-Salpetriere, Ospedale San Donato, Pontifícia Universidade Católica do Paraná, Royal Children's Hospital, University of Bern

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	Death from any cause	from inclusion to 20 years follow-up
Primary	Cardiac Death	Mortality due to cardiac cause	from inclusion to 20 years follow-up
Primary	Reoperation for Pulmonary Autograft Failure	Need for reoperation due to failure of pulmonary autograft or valve degeneration	from inclusion to 20 years follow-up
Primary	Stroke	neurological stroke with impairment	from inclusion to 20 years follow-up
Primary	Rehospitalization for heart failure	Readmission to hospital for heart failure	from inclusion to 20 years follow-up
Primary	Quality of life-1	Quality of life as measured with SF-12	from inclusion to 20 years follow-up
Primary	Quality of life-2	Quality of life as measured with Minnesota living with heart failure questionnaire	from inclusion to 20 years follow-up
Primary	Quality of life-3	Quality of life as measured withEQ 5D score	from inclusion to 20 years follow-up
Secondary	Postoperative complications	Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure	postoperative period (1-30 days)