Minimally Invasive Versus Conventional Aortic Valve Replacement: a Long Term Registry

Completed

• Conditions: Aortic Valve Surgery
• Interventions: Procedure: aortic valve replacement; Device: biological prosthetic valve; Device: Mechanical valve

• Registration Number: NCT02278666
• Lead Sponsor: Maria Cecilia Hospital

Brief Summary

The aim of the present study is to assess in a "real life" case list the outcome of three different surgical approaches for isolated aortic valve surgery in terms of surgery times, morbidity and mortality.

Detailed Description

The study will focus on data recorded and collected from daily clinical treatment of patients undergoing isolated aortic valve replacement due to symptomatic aortic stenosis who consented to the use of their personal data. After surgery patients will be followed up to a minimum of 12 months. In-hospital and follow-up outcomes of the different surgical approaches will be analysed.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-27
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-30
• Status Verified: 2022-07
• Primary Completion: 2022-11
• Study Completion: 2022-12
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients undergoing isolated aortic valve surgery
• Written Informed consent to the use of personal data

Exclusion Criteria

• other associated cardiac surgery
• emergency surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
upper mini-sternotomy	aortic valve replacement	aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)
right mini thoracotomy	Mechanical valve	aortic valve replacement/repair surgery via right mini thoracotomy
conventional sternotomy	aortic valve replacement	aortic valve replacement surgery via conventional full sternotomy
right mini thoracotomy	aortic valve replacement	aortic valve replacement/repair surgery via right mini thoracotomy
upper mini-sternotomy	Mechanical valve	aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)
right mini thoracotomy	biological prosthetic valve	aortic valve replacement/repair surgery via right mini thoracotomy
upper mini-sternotomy	biological prosthetic valve	aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)
conventional sternotomy	biological prosthetic valve	aortic valve replacement surgery via conventional full sternotomy
conventional sternotomy	Mechanical valve	aortic valve replacement surgery via conventional full sternotomy

Primary Outcome Measures

Name	Time	Method
Total duration of Intensive Care Unit stay	during hospital stay, usually lasting one to two weeks
Blood transfusions	during hospital stay, usually lasting one to two weeks
Cardiopulmonary bypass time	during surgery

Secondary Outcome Measures

Name	Time	Method
sepsis	during hospital stay, usually lasting one to two weeks
in-hospital mortality	during hospital stay, usually lasting one to two weeks
30-day mortality	30 days after surgery
Neurological complications	during hospital stay, usually lasting one to two weeks	stroke and/or transient ischemic attacks
Prolonged ventilation	during hospital stay	longer than 24 hours
renal insufficiency	during hospital stay, usually lasting one to two weeks	need for haemofiltration
Re-exploration for bleeding	during hospital stay, usually lasting one to two weeks	need of surgical revision for bleeding

Trial Locations

Locations (1)

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy