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Nitinol Circular Blade (NCB)

Primary Purpose

Aortic Valve Stenosis

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Aortic valve replacement using a nitinol blade

aortic valve replacement

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Parla ASTARCIRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Resection of the aortic valve leaflets with device

Resection of the aortic valve leaflets in standard fashion

Arm Description

Patients in which the aortic valve has been resected using the nitinol blade

Patients in which the aortic valve has been resected using a conventional blade or scissor

Outcomes

Primary Outcome Measures

Procedural success of the resection

Resection of the aortic valve leaflets by the circular nitinol blade

Secondary Outcome Measures

Complication due to the use of the device

Any complication related to the use of the nitinol blade

Full Information

NCT ID

NCT03881527

First Posted

October 7, 2015

Last Updated

March 18, 2019

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

1. Study Identification

Unique Protocol Identification Number

NCT03881527

Brief Title

Nitinol Circular Blade

Acronym

NCB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Resection of the aortic valve leaflets with device

Arm Type

Experimental

Arm Description

Patients in which the aortic valve has been resected using the nitinol blade

Arm Title

Resection of the aortic valve leaflets in standard fashion

Arm Type

Other

Arm Description

Patients in which the aortic valve has been resected using a conventional blade or scissor

Intervention Type

Device

Intervention Name(s)

Aortic valve replacement using a nitinol blade

Intervention Description

A circular nitinol blade will be inserted by to cut the aortic valve leaflets during conventional aortic valve replacement procedure

Intervention Type

Procedure

Intervention Name(s)

aortic valve replacement

Intervention Description

Aortic valve replacement in a standard fashion

Primary Outcome Measure Information:

Title

Procedural success of the resection

Description

Resection of the aortic valve leaflets by the circular nitinol blade

Time Frame

Hospital discharge : in average 1 week

Secondary Outcome Measure Information:

Title

Complication due to the use of the device

Description

Any complication related to the use of the nitinol blade

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Parla ASTARCI, MD PhD

Phone

+32 2 764 64 12

parla.astarci@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Emilano NAVARRA, MD

Phone

+32 764 61 07

emilano.navarra@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Parla ASTARCI, Md PhD

Organizational Affiliation

Cliniques universiatires St Luc

Official's Role

Principal Investigator

Facility Information:

Facility Name

Parla ASTARCI

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Parla Astarci, MD PhD

Phone

+32 764 64 12

parla.Astarci@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Parla ASTARCI, MD PhD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22437365

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.

Results Reference

result

PubMed Identifier

21256045

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 approaches using Edwards Sapiens valve. Eur J Cardiothorac Surg. 2011 Aug;40(2):475-9. doi: 10.1016/j.ejcts.2010.11.070. Epub 2011 Jan 20.

Results Reference

result

PubMed Identifier

21486757

Citation

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.

Results Reference

result

PubMed Identifier

22235001

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 2012 Jan 9.

Results Reference

result

PubMed Identifier

23610993

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. J Heart Valve Dis. 2013 Jan;22(1):79-84.

Results Reference

result

PubMed Identifier

23814136

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.

Results Reference

result

PubMed Identifier

23977499

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 Cardiothorac Surg. 2012 Jul;1(2):224-30. doi: 10.3978/j.issn.2225-319X.2012.06.15. No abstract available.

Results Reference

result

PubMed Identifier

24280965

Citation

Nuis RJ, Sinning JM, Rodes-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, Lopez J, Dumont E, van Mieghem N, van Gelder T, van Domburg RT, de Jaegere PP. Prevalence, factors associated with, and prognostic effects of preoperative anemia on short- and long-term mortality in patients undergoing transcatheter aortic valve implantation. Circ Cardiovasc Interv. 2013 Dec;6(6):625-34. doi: 10.1161/CIRCINTERVENTIONS.113.000409. Epub 2013 Nov 26.

Results Reference

result

PubMed Identifier

26139739

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 Anaesth. 2015 Jul-Sep;18(3):343-51. doi: 10.4103/0971-9784.159804.

Results Reference

result

PubMed Identifier

27032472

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. 2016 Sep;50(3):406-10. doi: 10.1093/ejcts/ezw027. Epub 2016 Mar 31.

Results Reference

result

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Nitinol Circular Blade

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