Mini-invasive Approaches to Aortic Surgery

NCT ID: NCT04350697

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2425 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgery Surgical Injury Surgical Procedure, Unspecified Surgical Incision Aortic Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Mini-Sternotomy

Patients underwent aortic surgery by Mini-Sternotomy

Aortic Surgery

Intervention Type PROCEDURE

Surgery for aortic and/or aortic valve diseases

Mini-Thoracotomy

Patients underwent aortic surgery by Mini-Thoracotomy

Aortic Surgery

Intervention Type PROCEDURE

Surgery for aortic and/or aortic valve diseases

Interventions

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Aortic Surgery

Surgery for aortic and/or aortic valve diseases

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

\- Indication for Aortic and/or Aortic Valve surgery

Exclusion Criteria

\- none
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof Sandro Gelsomino

UNKNOWN

Sponsor Role collaborator

Prof Edvin Prifti

UNKNOWN

Sponsor Role collaborator

Prof Guido Sani

UNKNOWN

Sponsor Role collaborator

Dr Aleksander Dokollari

UNKNOWN

Sponsor Role collaborator

University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Massimo Bonacchi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Massimo Bonacchi

Florence, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Bonacchi, Prof

Role: CONTACT

393389855782

Edvin Prifti, Prof

Role: CONTACT

Facility Contacts

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Massimo Bonacchi, MD

Role: primary

393389855782

References

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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.

Reference Type DERIVED
PMID: 33994208 (View on PubMed)

Other Identifiers

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MSvsMT

Identifier Type: -

Identifier Source: org_study_id

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