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Clinical Trials/NCT02278666
NCT02278666
Completed
N/A

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

Maria Cecilia Hospital1 site in 1 country1,000 target enrollmentOctober 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aortic Valve Surgery
Sponsor
Maria Cecilia Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Total duration of Intensive Care Unit stay
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
December 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Maria Cecilia Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Cardiopulmonary bypass time

Time Frame: during surgery

Secondary Outcomes

  • in-hospital mortality(during hospital stay, usually lasting one to two weeks)
  • 30-day mortality(30 days after surgery)
  • sepsis(during hospital stay, usually lasting one to two weeks)
  • Neurological complications(during hospital stay, usually lasting one to two weeks)
  • Prolonged ventilation(during hospital stay)
  • renal insufficiency(during hospital stay, usually lasting one to two weeks)
  • Re-exploration for bleeding(during hospital stay, usually lasting one to two weeks)

Study Sites (1)

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