Nitinol Circular Blade

Brief Title

Nitinol Circular Blade

Official Title

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

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.

Study Type

Interventional

Primary Outcome

Procedural success of the resection

Secondary Outcome

 Complication due to the use of the device

Condition

Aortic Valve Stenosis

Intervention

Aortic valve replacement using a nitinol blade

Study Arms / Comparison Groups

 Resection of the aortic valve leaflets with device

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

Start Date

October 2015

Completion Date

December 2019

Primary Completion Date

December 2019

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

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Parla ASTARCI, Md PhD, +32 2 764 64 12, [email protected]

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations

NCT ID

NCT03881527

Organization ID

2014/14OCT/513

Responsible Party

Sponsor

Study Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Sponsor

Parla ASTARCI, Md PhD, Principal Investigator, Cliniques universiatires St Luc

Verification Date

March 2019