Nitinol Circular Blade

Aortic Valve Stenosis Clinical Trial

— NCB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03881527
• Other study ID #: 2014/14OCT/513
• Status: Recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Parla ASTARCI, MD PhD
• Phone: +32 2 764 64 12
• Email: parla.astarci[@]uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Severe aortic stenosis defined as one or more of the following by Doppler echocardiography: mean gradient >40 mmHg; max velocity >4 m/sec; aortic valve area <=0.8 cm2.

• Symptoms related to aortic valve disease, and NYHA Functional Class II or greater

• Subject is indicated for aortic valve implantation with a biological prosthesis (tissue valve)

• Age >= 65 years

• Echocardiographically determined aortic annulus diameter >=24 mm and <=30 mm in a long-axis view

• Subject understands the implications of participating in the study and provides informed consent

Exclusion Criteria:

• Congenital unicuspid aortic valve

• Severe eccentricity of calcification, defined as calcium deposits larger than 6 mm in diameter

• Echocardiographic evidence of intracardiac mass, thrombus or vegetation

• Left ventricular ejection fraction <25% as determined by contrast ventriculography, or echocardiography or radionuclide angiography if contrast ventriculography not available

• Hypertrophic obstructive cardiomyopathy

• Subjects with life expectancy less than 12 months due to an underlying non-cardiac co-morbid disease

• Known hypersensitivity or contraindication that cannot be adequately controlled with pre-medication to any study medication or material, such as contrast medium or Nitinol

• Blood dyscrasia such as acute anemia, leucopenia, or thrombocytopenia; bleeding diathesis, or coagulopathy

• Renal insufficiency assessed by creatinine >2.5 mg/dl and/or end stage renal disease requiring chronic dialysis

• Poor lung function that in the investigator's opinion is prohibitive for thoracotomy

• Active peptic ulcer or GI bleeding within 3 months from the planned index procedure

• Cardiogenic shock, suspected cardiogenic shock, or hemodynamic instability requiring inotropic support or mechanical heart assistance

• Peripheral vascular disease, including abdominal and thoracic aortic disease, that could pose a problem for eventual transarterial mechanical support (e.g. intraaortic balloon pump)

• History of myocardial infarction in the last 6 weeks

• History of TIA or CVA in the last 6 months

• Subject refuses to have a blood transfusion

• Subject is currently enrolled in another investigational device or drug trial that may influence the outcome of this trial

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

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

Locations

Country	Name	City	State
Belgium	Parla ASTARCI	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (10)

Astarci P, Desiron Q, Glineur D, El Khoury G. Transapical explantation of an embolized transcatheter valve. Interact Cardiovasc Thorac Surg. 2011 Jul;13(1):1-2. doi: 10.1510/icvts.2011.267757. Epub 2011 Apr 11. — View Citation

Astarci P, Etienne PY, Raucent B, Bollen X, Tranduy K, Glineur D, Dekerchove L, Noirhomme P, Elkhoury G. Transcatheter resection of the native aortic valve prior to endovalve implantation - A rational approach to reduce TAVI-induced complications. Ann Car — View Citation

Astarci P, Glineur D, De Kerchove L, El Khoury G. Transcatheter valve used in a bailout technique during complicated open mitral valve surgery. Interact Cardiovasc Thorac Surg. 2013 Oct;17(4):745-7. doi: 10.1093/icvts/ivt249. Epub 2013 Jun 28. — View Citation

Astarci P, Glineur D, Elkhoury G, Raucent B. A novel device for endovascular native aortic valve resection for transapical transcatheter aortic valve implantation. Interact Cardiovasc Thorac Surg. 2012 Apr;14(4):378-80. doi: 10.1093/icvts/ivr125. Epub 201 — View Citation

Astarci P, Glineur D, Kefer J, D'Hoore W, Renkin J, Vanoverschelde JL, El Khoury G, Grandin C. Magnetic resonance imaging evaluation of cerebral embolization during percutaneous aortic valve implantation: comparison of transfemoral and trans-apical approa — View Citation

Astarci P, Glineur D, Kefer J, Renkin J, Vanoverschelde JL, El Khoury G. "Ring pledget": a new concept for secure apex closure during transapical aortic valve implantation. Innovations (Phila). 2010 Mar;5(2):136-7. doi: 10.1097/IMI.0b013e3181cbb364. — View Citation

Astarci P, Price J, Glineur D, D'Hoore W, Kefer J, Elkhoury G, Grandin C, Vanoverschelde JL. Cerebral embolization during percutaneous valve implantation does not occur during balloon inflation valvuloplasty: prospective diffusion-weighted brain MRI study — View Citation

Gauthier C, Astarci P, Baele P, Matta A, Kahn D, Kefer J, Momeni M. Mid-term survival after transcatheter aortic valve implantation: Results with respect to the anesthetic management and to the access route (transfemoral versus transapical). Ann Card Anae — View Citation

Navarra E, Mosala Nezhad Z, Bollen X, Gielen CE, Mastrobuoni S, De Kerchove L, Raucent B, Astarci P. Endovascular resection of the native aortic valve before transcatheter aortic valve implantation: state of the art and review. Eur J Cardiothorac Surg. 20 — View Citation

Nuis RJ, Sinning JM, Rodés-Cabau J, Gotzmann M, van Garsse L, Kefer J, Bosmans J, Yong G, Dager AE, Revilla-Orodea A, Urena M, Nickenig G, Werner N, Maessen J, Astarci P, Perez S, Benitez LM, Amat-Santos IJ, López J, Dumont E, van Mieghem N, van Gelder T, — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success of the resection	Resection of the aortic valve leaflets by the circular nitinol blade	Hospital discharge : in average 1 week
Secondary	Complication due to the use of the device	Any complication related to the use of the nitinol blade	1 year