AzTrials
AzTrials

Aortic Valve StenosisNCBNCT03881527

Nitinol Circular Blade

A study testing Aortic valve replacement using a nitinol blade and aortic valve replacement in people with Aortic Valve Stenosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
Aortic valve replacement using a nitinol blade and aortic valve replacement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBelgium
Study dates
Oct 2015to Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Parla ASTARCI, MD PhD contact

+32 2 764 64 12

parla.astarci@uclouvain.be

Emilano NAVARRA, MD contact

+32 764 61 07

emilano.navarra@uclouvain.be

Belgium1 site, 1 recruiting

  • Parla ASTARCI

    Brussels, 1200

    Parla Astarci, MD PhD, +32 764 64 12, parla.Astarci@uclouvain.be

    Parla ASTARCI, MD PhD

    Recruiting

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Being tested
Aortic valve replacement using a nitinol blade, aortic valve replacement
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aortic valve replacement using a nitinol bladeDevice

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

  • aortic valve replacementProcedure or surgery

    Aortic valve replacement in a standard fashion

Study groups in NCT03881527
Study groupRoleWhat they receive
Resection of the aortic valve leaflets with deviceExperimentalPatients in which the aortic valve has been resected using the nitinol blade
Receives: Device: Aortic valve replacement using a nitinol blade
Resection of the aortic valve leaflets in standard fashionOtherPatients in which the aortic valve has been resected using a conventional blade or scissor
Receives: Procedure: aortic valve replacement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Procedural success of the resection

    Resection of the aortic valve leaflets by the circular nitinol blade

    Measured: Hospital discharge : in average 1 week

Secondary outcomes (1)

  1. Complication due to the use of the device

    Any complication related to the use of the nitinol blade

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study startOct 2015
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03881527
Sponsor's protocol ID
2014/14OCT/513
Acronym
NCB
Status last verified
Mar 2019
First submitted
7 Oct 2015
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 22437365

  • 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.

    PubMed 21256045

  • 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.

    PubMed 21486757

  • 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.

    PubMed 22235001

  • 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.

    PubMed 23610993

  • 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.

    PubMed 23814136

  • 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.

    PubMed 23977499

  • 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.

    PubMed 24280965

  • 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.

    PubMed 26139739

  • 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.

    PubMed 27032472

Questions about this trial

What is this clinical trial studying?

A study testing Aortic valve replacement using a nitinol blade and aortic valve replacement in people with Aortic Valve Stenosis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Parla ASTARCI, MD PhD (+32 2 764 64 12, parla.astarci@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural success of the resection (time frame: Hospital discharge : in average 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03881527, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in