Nitinol Circular Blade (NCB)

March 18, 2019 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • Parla ASTARCI
        • Contact:
        • Principal Investigator:
          • Parla ASTARCI, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success of the resection
Time Frame: Hospital discharge : in average 1 week
Resection of the aortic valve leaflets by the circular nitinol blade
Hospital discharge : in average 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication due to the use of the device
Time Frame: 1 year
Any complication related to the use of the nitinol blade
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 18, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/14OCT/513

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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