Status:

COMPLETED

Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Lead Sponsor:

Karolinska University Hospital

Collaborating Sponsors:

Karolinska Institutet

Conditions:

Aortic Valve Stenosis

Heart Valve Diseases

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hun...

Eligibility Criteria

Inclusion

  • ≥ 18 years of age
  • Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
  • Referred for medically indicated aortic valve replacement
  • Sinus rhythm
  • Provide written informed consent

Exclusion

  • Inclusion in other trial
  • Left ventricular ejection fraction less than 0.45
  • Presence of any coexisting severe valvular disorder
  • Previous cardiac surgery
  • Urgent or emergent surgery

Key Trial Info

Start Date :

November 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2020

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT02272621

Start Date

November 1 2013

End Date

October 1 2020

Last Update

June 2 2021

Active Locations (1)

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1

Department of Cardiothoracic Surgery, Karolinska University Hospital

Stockholm, Sweden