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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial upper hemisternotomy aortic valve replacement | Experimental | Partial upper hemisternotomy AVR will be performed according to current standard of care practices. |
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| Full sternotomy aortic valve replacement | Experimental | Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive aortic valve replacement | Procedure |
| ||
| Full sternotomy aortic valve replacement |
| Measure | Description | Time Frame |
|---|---|---|
| Universal definition of perioperative bleeding in adult cardiac surgery | Within 3 days from surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiothoracic Surgery, Karolinska University Hospital | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38907320 | Derived | Bratt S, Dimberg A, Kastengren M, Lilford RD, Svenarud P, Sartipy U, Franco-Cereceda A, Dalen M. Bleeding in minimally invasive versus conventional aortic valve replacement. J Cardiothorac Surg. 2024 Jun 21;19(1):349. doi: 10.1186/s13019-024-02667-1. | |
| 38054555 | Derived | Kirmani BH, Jones SG, Muir A, Malaisrie SC, Chung DA, Williams RJ, Akowuah E. Limited versus full sternotomy for aortic valve replacement. Cochrane Database Syst Rev. 2023 Dec 6;12(12):CD011793. doi: 10.1002/14651858.CD011793.pub3. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| Procedure |
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