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RecruitingNCT04350697MSvsMTUpdated Apr 28, 2021

Mini-invasive Approaches to Aortic Surgery

An observational study in Surgery, Surgical Injury and Surgical Procedure, Unspecified, sponsored by University of Florence. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-28.

Sponsored by University of Florence · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2021, 4 years 9 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
2,425
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Surgery
  • Surgical Injury
  • Surgical Procedure, Unspecified
  • Surgical Incision
  • Aortic Surgery

Keywords

  • miniinvasive surgery
  • aortic surgery
  • minithoracotomy
  • ministernotomy
  • outcomes
  • surgical complications
03

In context

Intraoperative Complications

78 studies on the registry are indexed under Intraoperative Complications; 17 are open to participants now.

This study's planned enrollment of 2,425 is above the median of 160 across 35 observational studies indexed under Intraoperative Complications.

Browse Intraoperative Complications studies →

Lead sponsor

University of Florence is the lead sponsor of 75 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Indication for Aortic and/or Aortic Valve surgery

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
2,425 participants (estimated)
Patient registry
No

Groups and cohorts

  • Mini-Sternotomy

    Patients underwent aortic surgery by Mini-Sternotomy

    Procedure: Aortic Surgery

  • Mini-Thoracotomy

    Patients underwent aortic surgery by Mini-Thoracotomy

    Procedure: Aortic Surgery

Interventions

  • ProcedureAortic Surgery

    Surgery for aortic and/or aortic valve diseases

06

What researchers measure

Primary outcomes

  1. PO

    Post-Operative Survival

    Time frame: 1 day after surgery

Secondary outcomes

  1. EO

    Early Outcome (Survival)

    Time frame: 1 month after surgery

  2. MO

    Mid-term Outcome (Survival)

    Time frame: 5 years after surgery

  3. LO

    Late Outcome (Survival)

    Time frame: 10 years after surgery

  4. VLO

    Very-Late Outcome (Survival)

    Time frame: 20 years after surgery

07

Study locations

1 of 1 sites recruiting
  • Massimo Bonacchi
    Florence, 50144, Italy
    • Massimo Bonacchi, MD · Contact · mbonacchi@unifi.it · 393389855782
    • Sandro Gelsomino, MD · Sub investigator
    • Edvin Prifti, MD · Sub investigator
    • Aleksander Dokollari, MD · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04350697
Lead sponsor
University of Florence
Collaborators
Prof Sandro Gelsomino, Prof Edvin Prifti, Prof Guido Sani, Dr Aleksander Dokollari
Responsible party
Massimo Bonacchi (Professor, University of Florence) — Principal investigator
First posted
Apr 17, 2020
Start date
Jan 1, 1999
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Apr 28, 2021

Study contacts

Massimo Bonacchi, Prof
Contact
mbonacchi@unifi.it
393389855782
Edvin Prifti, Prof
Contact
edvinprifti@hotmail.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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