Aortic Aneurysm, ThoracicMIRAGENCT04814238
Minimally Invasive Aortic Root and Aorta surGery rEgistry
An observational study of Aortic Aneurysm, Thoracic, run by Nicolaus Copernicus University at 1 site in Poland.
Trial summary
Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm, Thoracic
- What is being tested?
- Aortic Root Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 sitePoland
- Study dates
- 22 Mar 2021to 1 Jan 2023
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients undergoing minimally-invasive aortic root and aorta surgery.
Who may be able to join
- isolated, first time aortic root or aorta surgery
Who cannot join
- active aortic valve endocarditis, redo surgery, acute type A dissection, and concomitant cardiac procedures.
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education
Warsaw
Jakub Staromłyński, MD, PhD, jakubstaromlynski@gmail.com
About this study
Official title: Multicentre Registry of Minimally Invasive Aorta and Aortic Root Surgeries in Patients With Aortic Aneurysms
Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Evidence exists, however, on safety of this approach together with promising results regarding its long-term durability. The MIRAGE Registry is aimed to collect and analyse the data from multiple aortic excellence centres and to analyse them in numerous clinical scenarios.
- Conditions
- Aortic Aneurysm, Thoracic
- Being tested
- Aortic Root Surgery
- Medical subject headings
- Aortic Aneurysm, Thoracic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aortic Root SurgeryProcedure or surgery
Also called Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement
First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery
| Study group | Role | What they receive |
|---|---|---|
| mini-David | Not described Receives: Procedure: Aortic Root Surgery | |
| mini-Yacoub | Not described Receives: Procedure: Aortic Root Surgery | |
| mini-Bentall | Not described Receives: Procedure: Aortic Root Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early (in-hospital/30-day) mortality
Measured: 30 days
Secondary outcomes (2)
Freedom from reoperation
Measured: 5 years
Long-term mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start22 Mar 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic Aneurysm, ThoracicStudies 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
- Other
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Nicolaus Copernicus University
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Prof. Franciszek Lukaszczyk Memorial Oncology Center, Centre of Postgraduate Medical Education
- Responsible party
- Principal investigator, Mariusz Kowalewski, Nicolaus Copernicus University
- Investigators
- Piotr Suwalski, MD, PhD, Study director, Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, PolandJakub Staromłyński, MD, PhD, Principal investigator, Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, PolandMariusz Kowalewski, MD, PhD, Principal investigator, Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814238
- Sponsor's protocol ID
- #1/2021
- Acronym
- MIRAGE
- Status last verified
- Mar 2021
- First submitted
- 22 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Staromlynski J, Kowalewski M, Sarnowski W, Smoczynski R, Witkowska A, Bartczak M, Drobinski D, Wierzba W, Suwalski P. Midterm results of less invasive approach to ascending aorta and aortic root surgery. J Thorac Dis. 2020 Nov;12(11):6446-6457. doi: 10.21037/jtd-20-2165.
PubMed 33282347Staromlynski J, Kowalewski M, Smoczynski R, Suwalski P. Minimally invasive approach to ascending aorta and aortic root surgery. Interact Cardiovasc Thorac Surg. 2021 Jan 1;32(1):163. doi: 10.1093/icvts/ivaa214. No abstract available.
PubMed 33372227
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Registry of Minimally Invasive Aorta and Aortic Root Surgeries in Patients With Aortic Aneurysms
- ClinicalTrials.gov ID
- NCT04814238
- Acronym / sponsor ID
- MIRAGE / #1/2021
- Conditions
- Aortic Aneurysm, Thoracic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nicolaus Copernicus UniversityUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Prof. Franciszek Lukaszczyk Memorial Oncology Center, Centre of Postgraduate Medical Education
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 24 Mar 2021 (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.
Minimally invasive aortic valve (AV) surgery has become widely accepted alternative to standard sternotomy. Despite possible reduction in morbidity, this approach is not routinely performed for aortic surgery. Evidence exists, however, on safety of this approach together with promising results regarding its long-term durability. The MIRAGE Registry is aimed to collect and analyse the data from multiple aortic excellence centres and to analyse them in numerous clinical scenarios.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mini-David | – | Procedure: Aortic Root Surgery |
| mini-Yacoub | – | Procedure: Aortic Root Surgery |
| mini-Bentall | – | Procedure: Aortic Root Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing minimally-invasive aortic root and aorta surgery.
Key inclusion criteria (1 listed)
- isolated, first time aortic root or aorta surgery
Key exclusion criteria (1 listed)
- active aortic valve endocarditis, redo surgery, acute type A dissection, and concomitant cardiac procedures.
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 Root SurgeryAlso: Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary ReplacementFirst time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery | Procedure or surgery | mini-Bentall, mini-David, mini-Yacoub |
Primary outcome
Early (in-hospital/30-day) mortality
Time frame: 30 days
2 secondary outcomes
Freedom from reoperation
Time frame: 5 years
Long-term mortality
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Background: PubMed 33282347Staromlynski J, Kowalewski M, Sarnowski W, Smoczynski R, Witkowska A, Bartczak M, Drobinski D, Wierzba W, Suwalski P. Midterm results of less invasive approach to ascending aorta and aortic root surgery. J Thorac Dis. 2020 Nov;12(11):6446-6457. doi: 10.21037/jtd-20-2165.
- Background: PubMed 33372227Staromlynski J, Kowalewski M, Smoczynski R, Suwalski P. Minimally invasive approach to ascending aorta and aortic root surgery. Interact Cardiovasc Thorac Surg. 2021 Jan 1;32(1):163. doi: 10.1093/icvts/ivaa214. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Piotr Suwalski, MD, PhD study director
Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
Jakub Staromłyński, MD, PhD principal investigator
Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
Mariusz Kowalewski, MD, PhD principal investigator
Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
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 Aneurysm, Thoracic, run by Nicolaus Copernicus University at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 24 Mar 2021. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariusz Kowalewski, MD, PhD (0048502269240, kowalewskimariusz@gazeta.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early (in-hospital/30-day) mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04814238, which also lists 2 linked publications.
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 24 Mar 2021; AzTrials last refreshed its copy on 31 Oct 2026.