Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis (SA-AVR)
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|ClinicalTrials.gov Identifier: NCT03976817|
Recruitment Status : Completed
First Posted : June 6, 2019
Last Update Posted : June 6, 2019
|Condition or disease||Intervention/treatment|
|Aortic Valve Disease Prosthesis; Cardiac, Heart, Functional Disturbance as Result||Procedure: aortic valve replacement|
|Study Type :||Observational|
|Actual Enrollment :||117 participants|
|Official Title:||Supra-annular Aortic Valve Replacement: Surgical Techniques and Early Outcomes|
|Actual Study Start Date :||February 1, 2018|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||April 1, 2019|
Patients who underwent the supra-annular aortic valve replacement (SA-AVR) technique in our institution between December 2010 and December 2017 were retrospectively reviewed.
Procedure: aortic valve replacement
After median sternotomy, cardiopulmonary bypass (CPB) was established between the ascending aorta and the right atrium. The aorta was cross-clamped and a high potassium warm cardioplegia was infused and repeated every 15 minutes. The aortotomy was made above the sinuses and the aortic valve was removed. The prosthesis was chosen one size larger than the maximal sizer that could be inserted, which was also used to determine the appropriate height for insertion of the sutures along the wall of the non-coronary sinus.
- In-hospital mortality [ Time Frame: Hospital discharge, an average 10 days ]
- Functional status [ Time Frame: 1 year after the surgery ]New York Heart Association functional class (from I to IV)
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): NCT03976817
|Hopital Marie Lannelongue|
|Le Plessis-Robinson, France, 92350|
|Study Chair:||Elie Fadel, MD PhD||Marie Lannelongue Hospital|