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

Overview

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.

Full Title of Study: “Minimally Invasive Aortic Valve Replacement Versus Conventional Aortic Valve Replacement: a Long Term Registry on Potential Benefits of the Different Surgical Techniques”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2022

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.

Interventions

  • Procedure: aortic valve replacement
    • aortic valve replacement with either biological prosthetic valve or mechanical valve
  • Device: biological prosthetic valve
    • aortic valve replacement with either biological prosthetic valve or mechanical valve
  • Device: Mechanical valve
    • aortic valve replacement with either biological prosthetic valve or mechanical valve

Arms, Groups and Cohorts

  • upper mini-sternotomy
    • aortic valve replacement surgery via upper J or T sternotomy (ministernotomy)
  • right mini thoracotomy
    • aortic valve replacement/repair surgery via right mini thoracotomy
  • conventional sternotomy
    • aortic valve replacement surgery via conventional full sternotomy

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Maria Cecilia Hospital
  • Collaborator
    • Ettore Sansavini Health Science Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Elisa Mikus, MD, Principal Investigator, Maria Cecilia Hospital

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