NCT03881527

Nitinol Circular Blade

Transaortic Native Valve Resection Using a Novel Nitinol Blade Device Rather Than a Classical Surgical Blade (Nitinol Circular Blade)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Aortic valve replacement using a nitinol blade	A circular nitinol blade will be inserted by to cut the aortic valve leaflets during conventional aortic valve replacement procedure
PROCEDURE	aortic valve replacement	Aortic valve replacement in a standard fashion

Timeline

• Start date: 2015-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2019-03-19
• Last updated: 2019-03-19

Locations

1 site across 1 country: Belgium