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NCT04350697 Clinical Trial

Mini-invasive Approaches to Aortic Surgery

Surgery Clinical Trial

— MSvsMT  

Official title:
Comparison Between Ministernotomy and Minithoracotomy for Aortic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04350697
Other study ID # MSvsMT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 1999
Est. completion date December 31, 2025

Study information
Verified date April 2020
Source University of Florence
Contact Massimo Bonacchi, Prof
Phone 393389855782
Email mbonacchi@unifi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2425
Est. completion date December 31, 2025
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Indication for Aortic and/or Aortic Valve surgery Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Aortic Surgery
Surgery for aortic and/or aortic valve diseases

Locations
Country Name City State
Italy Massimo Bonacchi Florence

Sponsors (5)
Lead Sponsor Collaborator
University of Florence Dr Aleksander Dokollari, Prof Edvin Prifti, Prof Guido Sani, Prof Sandro Gelsomino

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary PO Post-Operative Survival 1 day after surgery
Secondary EO Early Outcome (Survival) 1 month after surgery
Secondary MO Mid-term Outcome (Survival) 5 years after surgery
Secondary LO Late Outcome (Survival) 10 years after surgery
Secondary VLO Very-Late Outcome (Survival) 20 years after surgery
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