An interventional study of Aortic valve replacement using a nitinol blade and aortic valve replacement in Aortic Valve Stenosis, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Status unknown at 1 site in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2019-03-19.
Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Treatment
The Nitinol Circular Blade (NCB) is indicated for use in patients with symptomatic aortic stenosis requiring aortic valve replacement, who are going to be operated by conventional sternotomy with native valve resection and replacement by a prosthetic aortic valve. The resection of the diseased leaflets will be performed by the NCB rather than conventional surgical blade.
The patient will be under general anesthesia. The sternum will be opened fully or partially. The patient will be prepared for cardiopulmonary bypass. A transversal aortotomy will be performed as usual. The aortic valve will be exposed for the resection. The NCB will be inserted under visual control from the aorta to the left ventricle. The collection chamber will be closed and the circular blade can be advanced forward to resect the diseased native aortic valve. Once the resection is completed the device will be retrieved carefully. Complementary fine cleaning of the aortic annulus can be done by the surgeon in order to prepare the annulus to receive the prosthetic valve. After implantation of the new valve classically the aortotomy will be closed. Standard weaning of cardiopulmonary bypass will be done and the operation will be safely completed. The aim of this blade is to evaluate the resection time, test the efficiency of a circular Nitinol blade during resection of the calcified native aortic leaflets. A careful examination of the resection edges, aortic annulus, mitral valve and all surrounding tissues will be done in order to validate the efficacy of this Nitinol Circular Blade.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 40 is below the median of 120 across 525 interventional studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in which the aortic valve has been resected using the nitinol blade
Device: Aortic valve replacement using a nitinol blade
Patients in which the aortic valve has been resected using a conventional blade or scissor
Procedure: aortic valve replacement
A circular nitinol blade will be inserted by to cut the aortic valve leaflets during conventional aortic valve replacement procedure
Aortic valve replacement in a standard fashion
Procedural success of the resection
Resection of the aortic valve leaflets by the circular nitinol blade
Time frame: Hospital discharge : in average 1 week
Complication due to the use of the device
Any complication related to the use of the nitinol blade
Time frame: 1 year
Plan to share: Undecided
This study is status unknown, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain