Minimally Invasive Aortic Root and Aorta surGery rEgistry (MIRAGE)

March 22, 2021 updated by: Mariusz Kowalewski, Nicolaus Copernicus University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • isolated, first time aortic root or aorta surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mini-David
Procedure: Aortic Root Surgery
First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery
Other Names:
  • Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement
mini-Yacoub
Procedure: Aortic Root Surgery
First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery
Other Names:
  • Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement
mini-Bentall
Procedure: Aortic Root Surgery
First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery
Other Names:
  • Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early (in-hospital/30-day) mortality
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Freedom from reoperation
Time Frame: 5 years
5 years
Long-term mortality
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nicolaus Copernicus University

Collaborators

Maastricht University Medical Center
Centre of Postgraduate Medical Education
Prof. Franciszek Lukaszczyk Memorial Oncology Center

Investigators

  • Study Director: Piotr Suwalski, MD, PhD, Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
  • Principal Investigator: Jakub Staromłyński, MD, PhD, Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
  • Principal Investigator: Mariusz Kowalewski, MD, PhD, Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 22, 2021

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2023

Study Registration Dates

First Submitted

March 22, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2021

Last Update Submitted That Met QC Criteria

March 22, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #1/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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