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Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

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ClinicalTrials.gov Identifier: NCT02272621
Recruitment Status : Completed
First Posted : October 23, 2014
Last Update Posted : June 2, 2021
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Magnus Dalén, Karolinska University Hospital

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-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.

Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.


Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Diseases Procedure: Minimally invasive aortic valve replacement Procedure: Full sternotomy aortic valve replacement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : November 2013
Actual Primary Completion Date : October 2020
Actual Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Experimental: Partial upper hemisternotomy aortic valve replacement
Partial upper hemisternotomy AVR will be performed according to current standard of care practices.
Procedure: Minimally invasive aortic valve replacement
Experimental: Full sternotomy aortic valve replacement
Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.
Procedure: Full sternotomy aortic valve replacement



Primary Outcome Measures :
  1. Universal definition of perioperative bleeding in adult cardiac surgery [ Time Frame: Within 3 days from surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02272621


Locations
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Sweden
Department of Cardiothoracic Surgery, Karolinska University Hospital
Stockholm, Sweden
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
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Responsible Party: Magnus Dalén, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02272621    
Other Study ID Numbers: CMILE-bleeding
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Aortic Valve Disease
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction