Minimally Invasive Aortic Root and Aorta surGery rEgistry

NCT ID: NCT04814238

Last Updated: 2021-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-22

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Aneurysm, Thoracic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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mini-David

Aortic Root Surgery

Intervention Type PROCEDURE

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

mini-Yacoub

Aortic Root Surgery

Intervention Type PROCEDURE

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

mini-Bentall

Aortic Root Surgery

Intervention Type PROCEDURE

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

Interventions

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Aortic Root Surgery

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

Intervention Type PROCEDURE

Other Intervention Names

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Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role collaborator

Prof. Franciszek Lukaszczyk Memorial Oncology Center

OTHER

Sponsor Role collaborator

Centre of Postgraduate Medical Education

OTHER

Sponsor Role collaborator

Nicolaus Copernicus University

OTHER

Sponsor Role lead

Responsible Party

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Mariusz Kowalewski

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Piotr Suwalski, MD, PhD

Role: 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

Role: 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

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Department of Cardiac Surgery, Central Clinical Hospital of the Ministry of Interior and Administration, Centre of Postgraduate Medical Education

Warsaw, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Mariusz Kowalewski, MD, PhD

Role: CONTACT

0048502269240

Facility Contacts

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Jakub Staromłyński, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33282347 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33372227 (View on PubMed)

Other Identifiers

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#1/2021

Identifier Type: -

Identifier Source: org_study_id

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