Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
Primary Purpose
Aortic Valve Stenosis, Heart Valve Diseases
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Minimally invasive aortic valve replacement
Full sternotomy aortic valve replacement
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Stenosis
Eligibility 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
Sites / Locations
- Department of Cardiothoracic Surgery, Karolinska University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Partial upper hemisternotomy aortic valve replacement
Full sternotomy aortic valve replacement
Arm Description
Partial upper hemisternotomy AVR will be performed according to current standard of care practices.
Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.
Outcomes
Primary Outcome Measures
Universal definition of perioperative bleeding in adult cardiac surgery
Secondary Outcome Measures
Full Information
NCT ID
NCT02272621
First Posted
October 21, 2014
Last Updated
May 31, 2021
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT02272621
Brief Title
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Heart Valve Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Partial upper hemisternotomy aortic valve replacement
Arm Type
Experimental
Arm Description
Partial upper hemisternotomy AVR will be performed according to current standard of care practices.
Arm Title
Full sternotomy aortic valve replacement
Arm Type
Experimental
Arm Description
Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.
Intervention Type
Procedure
Intervention Name(s)
Minimally invasive aortic valve replacement
Intervention Type
Procedure
Intervention Name(s)
Full sternotomy aortic valve replacement
Primary Outcome Measure Information:
Title
Universal definition of perioperative bleeding in adult cardiac surgery
Time Frame
Within 3 days from surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Cardiothoracic Surgery, Karolinska University Hospital
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
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