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NCT04814238 Clinical Trial

Minimally Invasive Aortic Root and Aorta surGery rEgistry

Aortic Aneurysm, Thoracic Clinical Trial

— MIRAGE  

Official title:
Multicentre Registry of Minimally Invasive Aorta and Aortic Root Surgeries in Patients With Aortic Aneurysms

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04814238
Other study ID # #1/2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 22, 2021
Est. completion date January 1, 2023

Study information
Verified date March 2021
Source Nicolaus Copernicus University
Contact Mariusz Kowalewski, MD, PhD
Phone 0048502269240
Email kowalewskimariusz@gazeta.pl
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2000
Est. completion date January 1, 2023
Est. primary completion date January 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Aortic Root Surgery
First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery

Locations
Country Name City State
Poland Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education Warsaw

Sponsors (4)
Lead Sponsor Collaborator
Nicolaus Copernicus University Centre of Postgraduate Medical Education, Maastricht University Medical Center, Prof. Franciszek Lukaszczyk Memorial Oncology Center

Country where clinical trial is conducted

Poland, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Early (in-hospital/30-day) mortality 30 days
Secondary Freedom from reoperation 5 years
Secondary Long-term mortality 5 years
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