NCT03881527

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2015

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 19, 2019

Status Verified

March 1, 2019

Enrollment Period

4.2 years

First QC Date

October 7, 2015

Last Update Submit

March 18, 2019

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

  • Procedural success of the resection

    Resection of the aortic valve leaflets by the circular nitinol blade

    Hospital discharge : in average 1 week

Secondary Outcomes (1)

  • Complication due to the use of the device

    1 year

Study Arms (2)

Resection of the aortic valve leaflets with device

EXPERIMENTAL

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

Device: Aortic valve replacement using a nitinol blade

Resection of the aortic valve leaflets in standard fashion

OTHER

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

Procedure: aortic valve replacement

Interventions

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

Resection of the aortic valve leaflets with device
aortic valve replacementPROCEDURE

Aortic valve replacement in a standard fashion

Resection of the aortic valve leaflets in standard fashion

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parla ASTARCI

Brussels, 1200, Belgium

RECRUITING

Related Publications (10)

  • 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.

    PMID: 22437365RESULT

  • 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.

    PMID: 21256045RESULT

  • 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.

    PMID: 21486757RESULT

  • 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.

    PMID: 22235001RESULT

  • 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.

    PMID: 23610993RESULT

  • 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.

    PMID: 23814136RESULT

  • 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.

    PMID: 23977499RESULT

  • 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.

    PMID: 24280965RESULT

  • 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.

    PMID: 26139739RESULT

  • 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.

    PMID: 27032472RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis ImplantationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationThoracic Surgical Procedures

Study Officials

  • Parla ASTARCI, Md PhD

    Cliniques universiatires St Luc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Parla ASTARCI, MD PhD

CONTACT

+32 2 764 64 12parla.astarci@uclouvain.be

Emilano NAVARRA, MD

CONTACT

+32 764 61 07emilano.navarra@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2015

First Posted

March 19, 2019

Study Start

October 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 19, 2019

Record last verified: 2019-03

Locations

BE(1)