Clinical trial NCT04814238: Minimally Invasive Aortic Root and Aorta surGery rEgistry
Official title: Multicentre Registry of Minimally Invasive Aorta and Aortic Root Surgeries in Patients With Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Aneurysm, Thoracic
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Prof. Franciszek Lukaszczyk Memorial Oncology Center
name: Centre of Postgraduate Medical Education
First posted: 2021-03-24
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing minimally-invasive aortic root and aorta surgery.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Early (in-hospital/30-day) mortality
timeFrame: 30 days
Secondary outcomes:
measure: Freedom from reoperation
timeFrame: 5 years
measure: Long-term mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education
Study officials:
affiliation: Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
name: Piotr Suwalski, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
name: Jakub Staromłyński, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education, Warsaw, Poland
name: Mariusz Kowalewski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. No abstract available.