Aortic Valve DiseaseRVAOMITAVANCT04455165
Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement
An observational study of Aortic Valve Disease, run by Centre Hospitalier La Chartreuse at 1 site in France.
Trial summary
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Valve Disease
- What is being tested?
- Aortic valve replacement
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2020to 29 Jun 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patient operated for aortic valve replacement with or without associated cardiac surgery from 2009 in Dijon University Hospital
Who may be able to join
- Patients > 18 y-o who underwent aortic valve replacement
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
France1 site
Cardiovascular and thoracic surgery Unit - Dijon University Hopital
Dijon, 21000
About this study
Official title: Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.
- Conditions
- Aortic Valve Disease
- Being tested
- Aortic valve replacement
- Medical subject headings
- Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic valve replacementProcedure or surgery
Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)
| Study group | Role | What they receive |
|---|---|---|
| RVAo MITAVA | Patient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital Receives: Procedure: Aortic valve replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 days mortality incidence rates
Mortality from aortic valve replacement to 30 days post-surgery
Measured: 30 days
Secondary outcomes (2)
30 days morbidity incidence rates
Morbidity from aortic valve replacement to 30 days post-surgery (major adverse cardiac events)
Measured: 30 days
Long-term morbimortality incidence rates
Morbimortality from aortic valve replacement up to 10 years post-surgery
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start29 Jun 2020
- Primary completion29 Jun 2020
- Study completion29 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve DiseaseStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier La Chartreuse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MORGANT Marie-Catherine, Centre Hospitalier La Chartreuse
- Investigators
- Marie-Catherine MORGANT, MD, Principal investigator, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455165
- Sponsor's protocol ID
- CCVT-RVAoMITAVARegistry
- Acronym
- RVAOMITAVA
- Status last verified
- Jul 2020
- First submitted
- 29 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement Operated at Dijon University Hospital
- ClinicalTrials.gov ID
- NCT04455165
- Acronym / sponsor ID
- RVAOMITAVA / CCVT-RVAoMITAVARegistry
- Conditions
- Aortic Valve Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Centre Hospitalier La ChartreuseUniversity, hospital or other
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 29 Jun 2020 (actual)
- Study completion
- 29 Jun 2020 (actual)
- First posted
- 2 Jul 2020 (actual)
- 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.
Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RVAo MITAVA | – | Procedure: Aortic valve replacementPatient operated since 2009 for aortic valve replacement through right anterior minithoracotomy approch in Dijon Burgundy University Hospital |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patient operated for aortic valve replacement with or without associated cardiac surgery from 2009 in Dijon University Hospital
Key inclusion criteria (1 listed)
- Patients > 18 y-o who underwent aortic valve replacement
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Aortic valve replacementAortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...) | Procedure or surgery | RVAo MITAVA |
Primary outcome
30 days mortality incidence rates
Time frame: 30 days
Mortality from aortic valve replacement to 30 days post-surgery
2 secondary outcomes
30 days morbidity incidence rates
Time frame: 30 days
Long-term morbimortality incidence rates
Time frame: 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No. All patients signed a institutional form prior to the procedure stating that they did not object to the use of their medical data for research purposes. Before inclusion, all patients (or a trusted person) were informed about the study and its objectives. No opposition was expressed.
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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.
Marie-Catherine MORGANT, MD principal investigator
Centre Hospitalier Universitaire Dijon
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 Aortic Valve Disease, run by Centre Hospitalier La Chartreuse 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: finished, as of the sponsor's last update on 7 Jul 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
30 days mortality incidence rates (time frame: 30 days). 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 Jul 2020.