Mini-invasive Approaches to Aortic Surgery (MSvsMT)

April 27, 2021 updated by: Massimo Bonacchi, University of Florence

Comparison Between Ministernotomy and Minithoracotomy for Aortic Surgery

There are many different types of mini-invasive approaches to aortic surgery. Ministernotomy and anterior right minithoracotomy are the two main techniques applied for minimally invasive aortic valve replacement, but if one of them is superior in terms of patient outcomes it is not still clear. Therefore, the aim of this study is to compare the immediate and long-term outcomes of these two techniques.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2425

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 Contact Backup

Study Locations

  • Italy
      • Florence, Italy, 50144
        • Recruiting
        • Massimo Bonacchi
        • Contact:
        • Sub-Investigator:
          • Sandro Gelsomino, MD
        • Sub-Investigator:
          • Edvin Prifti, MD
        • Sub-Investigator:
          • Aleksander Dokollari, MD

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing surgery for Aortic and/or Aortic Valve by miniinvasive approaches (ministernotomy or minithoracotomy)

Description

Inclusion Criteria:

- Indication for Aortic and/or Aortic Valve surgery

Exclusion Criteria:

- none

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-Sternotomy
Patients underwent aortic surgery by Mini-Sternotomy
Procedure: Aortic Surgery
Surgery for aortic and/or aortic valve diseases
Mini-Thoracotomy
Patients underwent aortic surgery by Mini-Thoracotomy
Procedure: Aortic Surgery
Surgery for aortic and/or aortic valve diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PO
Time Frame: 1 day after surgery
Post-Operative Survival
1 day after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EO
Time Frame: 1 month after surgery
Early Outcome (Survival)
1 month after surgery
MO
Time Frame: 5 years after surgery
Mid-term Outcome (Survival)
5 years after surgery
LO
Time Frame: 10 years after surgery
Late Outcome (Survival)
10 years after surgery
VLO
Time Frame: 20 years after surgery
Very-Late Outcome (Survival)
20 years after surgery

Collaborators and Investigators

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

Sponsor

University of Florence

Collaborators

Prof Sandro Gelsomino
Prof Edvin Prifti
Prof Guido Sani
Dr Aleksander Dokollari

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

January 1, 1999

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSvsMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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