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Nitinol Circular Blade (NCB)

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ClinicalTrials.gov Identifier: NCT03881527
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Device: Aortic valve replacement using a nitinol blade Procedure: aortic valve replacement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transaortic Native Valve Resection Using a Novel Nitinol Blade Device Rather Than a Classical Surgical Blade (Nitinol Circular Blade)
Study Start Date : October 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Resection of the aortic valve leaflets with device
Patients in which the aortic valve has been resected using the nitinol blade
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

Resection of the aortic valve leaflets in standard fashion
Patients in which the aortic valve has been resected using a conventional blade or scissor
Procedure: aortic valve replacement
Aortic valve replacement in a standard fashion




Primary Outcome Measures :
  1. Procedural success of the resection [ Time Frame: Hospital discharge : in average 1 week ]
    Resection of the aortic valve leaflets by the circular nitinol blade


Secondary Outcome Measures :
  1. Complication due to the use of the device [ Time Frame: 1 year ]
    Any complication related to the use of the nitinol blade



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881527


Contacts
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Contact: Parla ASTARCI, MD PhD +32 2 764 64 12 parla.astarci@uclouvain.be
Contact: Emilano NAVARRA, MD +32 764 61 07 emilano.navarra@uclouvain.be

Locations
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Belgium
Parla ASTARCI Recruiting
Brussels, Belgium, 1200
Contact: Parla Astarci, MD PhD    +32 764 64 12    parla.Astarci@uclouvain.be   
Principal Investigator: Parla ASTARCI, MD PhD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Parla ASTARCI, Md PhD Cliniques universiatires St Luc

Publications of Results:

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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03881527     History of Changes
Other Study ID Numbers: 2014/14OCT/513
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction