Mini-invasive Approaches to Aortic Surgery | NCT04350697

Studies
Mini-invasive Approaches to Aortic Surgery

NCT04350697

Sponsor

University of Florence

Status

Unknown status

Last Update Posted

Apr 28, 2021Actual

Enrollment

2,425Estimated

Phase

Not provided

Conditions

Surgery
Surgical Injury
Surgical Procedure, Unspecified
Surgical Incision
Aortic Surgery

Interventions

Aortic Surgery

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 1999

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Apr 7, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2021

Last Update Posted Date

Apr 28, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Massimo Bonacchi, Professor, University of FlorencePrincipal Investigator

Lead Sponsor

University of FlorenceOTHER

Collaborators

Name	Class
Prof Sandro Gelsomino	UNKNOWN
Prof Edvin Prifti	UNKNOWN
Prof Guido Sani	UNKNOWN
Dr Aleksander Dokollari

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,425Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aortic Surgery	Procedure	Surgery for aortic and/or aortic valve diseases	Mini-Sternotomy Mini-Thoracotomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
EO	Early Outcome (Survival)	1 month after surgery
MO	Mid-term Outcome (Survival)	5 years after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Indication for Aortic and/or Aortic Valve surgery

Exclusion Criteria:

- none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Massimo Bonacchi, Prof	Contact	393389855782		mbonacchi@unifi.it
Edvin Prifti, Prof	Contact			edvinprifti@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massimo Bonacchi	Recruiting	Florence		50144	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33994208	Derived	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.

ID	Term
D007431	Intraoperative Complications
D000072836	Surgical Wound

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014947	Wounds and Injuries