Ross OperationROFDANCT03027804
Ross Operation Failure Database
An observational study of Ross Operation and Pulmonary Autograft, run by Centre Cardiologique du Nord at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 80 years
- Conditions the study is for
- Ross Operation, Pulmonary Autograft, Structural Valve Degeneration
- What is being tested?
- Ross Operation
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Mar 2019
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergone (or undergoing) to Ross Operation
Who may be able to join
- Patients undergone (or undergoing) to Ross Operation
Who cannot join
- Patients requiring combined cardiac surgical procedure in association to Ross Operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ross Operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ross OperationProcedure or surgery
Replacement of the aortic valve by means of pulmonary artery autograft
| Study group | Role | What they receive |
|---|---|---|
| Ross Operation | Patients undergone Ross Operation. Patients requiring reoperation Receives: Procedure: Ross Operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Death from any cause
Measured: from inclusion to 20 years follow-up
Cardiac Death
Mortality due to cardiac cause
Measured: from inclusion to 20 years follow-up
Reoperation for Pulmonary Autograft Failure
Need for reoperation due to failure of pulmonary autograft or valve degeneration
Measured: from inclusion to 20 years follow-up
Stroke
neurological stroke with impairment
Measured: from inclusion to 20 years follow-up
Rehospitalization for heart failure
Readmission to hospital for heart failure
Measured: from inclusion to 20 years follow-up
Quality of life-1
Quality of life as measured with SF-12
Measured: from inclusion to 20 years follow-up
Quality of life-2
Quality of life as measured with Minnesota living with heart failure questionnaire
Measured: from inclusion to 20 years follow-up
Quality of life-3
Quality of life as measured withEQ 5D score
Measured: from inclusion to 20 years follow-up
Secondary outcomes (1)
Postoperative complications
Combined outcome including bleeding, arrhythmia, respiratory failure, renal failure
Measured: postoperative period (1-30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start1 Sep 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Why it stopped: This study has been changed in systematic review and meta-analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ross OperationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre Cardiologique du Nord
- Sponsor type
- University, hospital or other
- Collaborators
- Golden Jubilee National Hospital, University of Bern, Pontifícia Universidade Católica do Paraná, Ospedale San Donato, Groupe Hospitalier Pitie-Salpetriere, Royal Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Francesco Nappi, MD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027804
- Sponsor's protocol ID
- CN-17-001
- Acronym
- ROFDA
- Status last verified
- Jun 2023
- First submitted
- 18 Jan 2017
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Database on Ross Operation Failures and Outcomes
- ClinicalTrials.gov ID
- NCT03027804
- Acronym / sponsor ID
- ROFDA / CN-17-001
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: This study has been changed in systematic review and meta-analysis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Cardiologique du NordUniversity, hospital or other
- Collaborators
- Golden Jubilee National Hospital, University of Bern, Pontifícia Universidade Católica do Paraná, Ospedale San Donato, Groupe Hospitalier Pitie-Salpetriere, Royal Children's Hospital
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ross Operation | – | Procedure: Ross OperationPatients undergone Ross Operation. Patients requiring reoperation |
Who may qualify
- Ages
- 1 day to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergone (or undergoing) to Ross Operation
Key inclusion criteria (1 listed)
- Patients undergone (or undergoing) to Ross Operation
Key exclusion criteria (1 listed)
- Patients requiring combined cardiac surgical procedure in association to Ross Operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ross OperationReplacement of the aortic valve by means of pulmonary artery autograft | Procedure or surgery | Ross Operation |
Primary outcome
Survival
Time frame: from inclusion to 20 years follow-up
Death from any cause
Cardiac Death
Time frame: from inclusion to 20 years follow-up
Mortality due to cardiac cause
Reoperation for Pulmonary Autograft Failure
Time frame: from inclusion to 20 years follow-up
Need for reoperation due to failure of pulmonary autograft or valve degeneration
Stroke
Time frame: from inclusion to 20 years follow-up
neurological stroke with impairment
Rehospitalization for heart failure
Time frame: from inclusion to 20 years follow-up
Readmission to hospital for heart failure
Quality of life-1
Time frame: from inclusion to 20 years follow-up
Quality of life as measured with SF-12
Quality of life-2
Time frame: from inclusion to 20 years follow-up
Quality of life as measured with Minnesota living with heart failure questionnaire
Quality of life-3
Time frame: from inclusion to 20 years follow-up
Quality of life as measured withEQ 5D score
1 secondary outcome
Postoperative complications
Time frame: postoperative period (1-30 days)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Nappi, MD principal investigator
Centre Cardiologique du Nord
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ross Operation and Pulmonary Autograft, run by Centre Cardiologique du Nord at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: from inclusion to 20 years follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.