NCT04350697

Brief 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.

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
2,425

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 1999

Completed
21.3 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2020

Enrollment Period

23 years

First QC Date

April 7, 2020

Last Update Submit

April 27, 2021

Conditions

Keywords

miniinvasive surgeryaortic surgeryminithoracotomyministernotomyoutcomessurgical complications

Outcome Measures

Primary Outcomes (1)

  • PO

    Post-Operative Survival

    1 day after surgery

Secondary Outcomes (4)

  • EO

    1 month after surgery

  • MO

    5 years after surgery

  • LO

    10 years after surgery

  • VLO

    20 years after surgery

Study Arms (2)

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

Surgery for aortic and/or aortic valve diseases

Mini-SternotomyMini-Thoracotomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- Indication for Aortic and/or Aortic Valve surgery

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massimo Bonacchi

Florence, 50144, Italy

RECRUITING

Related Publications (1)

  • Bonacchi M, Dokollari A, Parise O, Sani G, Prifti E, Bisleri G, Gelsomino S. Ministernotomy compared with right anterior minithoracotomy for aortic valve surgery. J Thorac Cardiovasc Surg. 2023 Mar;165(3):1022-1032.e2. doi: 10.1016/j.jtcvs.2021.03.125. Epub 2021 Apr 23.

MeSH Terms

Conditions

Intraoperative ComplicationsSurgical Wound

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Massimo Bonacchi, Prof

CONTACT

Edvin Prifti, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 17, 2020

Study Start

January 1, 1999

Primary Completion

December 31, 2021

Study Completion

December 31, 2025

Last Updated

April 28, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations