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Status unknownNCT04814238MIRAGEUpdated Mar 24, 2021

Minimally Invasive Aortic Root and Aorta surGery rEgistry

An observational study in Aortic Aneurysm, Thoracic, sponsored by Nicolaus Copernicus University. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-24.

Sponsored by Nicolaus Copernicus University · Observational

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Aortic Aneurysm, Thoracic
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In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 151 across 443 observational studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

Nicolaus Copernicus University is the lead sponsor of 19 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients undergoing minimally-invasive aortic root and aorta surgery.

Inclusion criteria

  • isolated, first time aortic root or aorta surgery

Exclusion criteria

Exclusion Criteria:

  • active aortic valve endocarditis, redo surgery, acute type A dissection, and concomitant cardiac procedures.
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • mini-David

    Procedure: Aortic Root Surgery

  • mini-Yacoub

    Procedure: Aortic Root Surgery

  • mini-Bentall

    Procedure: Aortic Root Surgery

Interventions

  • ProcedureAortic Root Surgery

    First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery

    Also known as: Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement

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What researchers measure

Primary outcomes

  1. Early (in-hospital/30-day) mortality

    Time frame: 30 days

Secondary outcomes

  1. Freedom from reoperation

    Time frame: 5 years

  2. Long-term mortality

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education
    Warsaw, Poland
    Recruiting
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References and documents

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 33282347 ↗
  • Staromlynski 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04814238
Lead sponsor
Nicolaus Copernicus University
Collaborators
Maastricht University Medical Center, Prof. Franciszek Lukaszczyk Memorial Oncology Center, Centre of Postgraduate Medical Education
Responsible party
Mariusz Kowalewski (MD, PhD, Nicolaus Copernicus University) — Principal investigator
First posted
Mar 24, 2021
Start date
Mar 22, 2021
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2023 (estimated)
Last update
Mar 24, 2021

Study contacts

Mariusz Kowalewski, MD, PhD
Contact
kowalewskimariusz@gazeta.pl
0048502269240
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

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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