NCT04814238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

March 22, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 22, 2021

Last Update Submit

March 22, 2021

Conditions

Aortic Aneurysm, Thoracic

Outcome Measures

Primary Outcomes (1)

  • Early (in-hospital/30-day) mortality

    30 days

Secondary Outcomes (2)

  • Freedom from reoperation

    5 years

  • Long-term mortality

    5 years

Study Arms (3)

mini-David

Procedure: Aortic Root Surgery

mini-Yacoub

Procedure: Aortic Root Surgery

mini-Bentall

Procedure: Aortic Root Surgery

Interventions

Aortic Root SurgeryPROCEDURE

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

Also known as: Ascending Aorta Aneurysm Surgery, Aortoplasty, Supracoronary Replacement
mini-Bentallmini-Davidmini-Yacoub

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • isolated, first time aortic root or aorta surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Warsaw, Poland

RECRUITING

Related 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.

    PMID: 33282347BACKGROUND

  • 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.

    PMID: 33372227BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • 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

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariusz Kowalewski, MD, PhD

CONTACT

0048502269240kowalewskimariusz@gazeta.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 22, 2021

First Posted

March 24, 2021

Study Start

March 22, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2023

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations

PL(1)