NCT03027804

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

January 18, 2017

Last Update Submit

June 6, 2023

Conditions

Ross OperationPulmonary AutograftStructural Valve Degeneration

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Postoperative complications

    postoperative period (1-30 days)

Study Arms (1)

Ross Operation

Patients undergone Ross Operation. Patients requiring reoperation

Procedure: Ross Operation

Interventions

Ross OperationPROCEDURE

Replacement of the aortic valve by means of pulmonary artery autograft

Ross Operation

Eligibility Criteria

Age1 Day - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergone (or undergoing) to Ross Operation

You may qualify if:

  • Patients undergone (or undergoing) to Ross Operation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Cardiologique Du Nord

Paris, France

Location

Study Officials

  • Francesco Nappi, MD

    Centre Cardiologique du Nord

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2017

First Posted

January 23, 2017

Study Start

September 1, 2018

Primary Completion

January 1, 2019

Study Completion

March 1, 2019

Last Updated

June 7, 2023

Record last verified: 2023-06

Locations

FR(1)