Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
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|ClinicalTrials.gov Identifier: NCT02272621|
Recruitment Status : Recruiting
First Posted : October 23, 2014
Last Update Posted : July 19, 2017
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. Twenty patients will be randomly assigned to either partial upper sternotomy (20 patients) or full sternotomy AVR (20 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.
CE-marked and FDA-approved mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Cytokine release will be repeatedly assessed preoperatively and postoperatively (at 0, 6, 12, 18, 24 hours, and 3 days after surgery). Clinical characteristics will be registered. Clinical postoperative ouytcomes 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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
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
- Interleukin-6 [ Time Frame: Postoperatively at 0-3 days ]
- Interleukin-8 [ Time Frame: Postoperatively at 0-3 days ]
- Interleukin-10 [ Time Frame: Postoperatively at 0-3 days ]
- Tumor necrosis factor-alpha [ Time Frame: Postoperatively at 0-3 days ]
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
|Contact: Peter Svenarud, MD, PhD||+46 (0) 8 517 708 email@example.com|
|Department of Cardiothoracic Surgery and Anesthesiology, Karolinska University Hospital||Recruiting|
|Contact: Peter Svenarud, MD, PhD +46 (0) 8 517 708 12 firstname.lastname@example.org|
|Principal Investigator: Peter Svenarud, MD, PhD|
|Sub-Investigator: Magnus Dalén, MD|
|Sub-Investigator: Ulrik Sartipy, MD, PhD|
|Sub-Investigator: Anders Franco-Cereceda, MD, PhD|
|Sub-Investigator: Mikael Kastengren, MD|