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ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909556
Recruitment Status : Active, not recruiting
First Posted : September 21, 2016
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation ( Symetis SA )

Brief Summary:
Cinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Condition or disease Intervention/treatment Phase
Aortic Stenosis Device: Transcatheter aortic valve replacement Not Applicable

Detailed Description:

Single arm, prospecitve, multicenter, non-randomized and open trial. The purpose of this trial is to collect and safety and performance data concerning the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System

The ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in patients presenting with severe aortic valve stenosis.

The primary objective is to evaluate the safety and performance of the study device in patients presenting with severe aortic stenosis (AS) considered to be high risk for surgery.

The secondary objective is to evaluate adverse events and study device performance.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis
Actual Study Start Date : December 16, 2016
Actual Primary Completion Date : January 24, 2018
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACURATE neo AS Device: Transcatheter aortic valve replacement
Transcatheter aortic valve replacement via transfemoral access
Other Names:
  • ACURATE neo™ AS Aortic Bioprosthesis
  • ACURATE neo™ AS TF Transfemoral Delivery System




Primary Outcome Measures :
  1. Rate of all-cause mortality at 30 days follow-up [ Time Frame: 30 days post-implant ]

Secondary Outcome Measures :
  1. Rate of clinical events as defined per VARC guidelines [ Time Frame: 7 days, 30 days, 12 months post-implant ]

    Clinical events:

    • Mortality
    • Stroke
    • Myocardial infarction
    • Bleeding complication
    • Acute kidney injury
    • Vascular complication
    • Conduction disturbances and arrhythmia
    • Other TAVI-related complications

  2. Procedural success [ Time Frame: Day of implant ]
    2. Procedural success defined as absence of complications arising during implantation of the prosthetic valve such as: inability to properly seat the valve in the annulus; need for more than one aortic bioprosthesis (valve in valve); or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication

  3. Device success [ Time Frame: Day of implant ]

    3. Device success defined as:

    • Absence of intra-procedure mortality AND,
    • Correct positioning of a single prosthetic heart valve into the proper anatomical location AND,
    • Intended performance of the prosthetic heart valve (EOAi >0.85 cm2/m2 and mean aortic valve gradient <20mmHg without moderate or severe AR)

  4. VARC Composite Safety at 30 days [ Time Frame: 30 days ]
  5. Clinical improvement from baseline as per NYHA Functional Classification [ Time Frame: 7 days, 30 days, 12 months post-implant ]
  6. Improvement from baseline in hemodynamic function: effective orifice area, mean transprosthetic gradient [ Time Frame: 7 days, 30 days, 12 months ]
  7. Total aortic regurgitation [ Time Frame: 7 days, 30 days, 12 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient 75 years of age and older
  2. Severe aortic stenosis defined as:

    • Mean aortic gradient > 40 mmHg or
    • Peak jet velocity > 4.0 m/s or
    • Aortic valve area of < 1.0 cm2
  3. High risk candidate for conventional AVR defined as:

    • Logistic EuroSCORE 1 ≥ 20% or
    • STS Score ≥ 8% or
    • Heart team (cardiologist and cardiac surgeon) consensus that patient is not a surgical candidate for conventional AVR due to significant co-morbid conditions unrelated to aortic stenosis
  4. NYHA Functional Class > II
  5. Aortic annulus diameter from ≥ 21mm up to ≤ 27mm by CT
  6. Patient willing to participate in the study and provides signed informed consent

Exclusion Criteria:

  1. Congenital aortic stenosis or unicuspid or bicuspid aortic valve
  2. Non-stenotic Aortic Insufficiency
  3. Severe eccentricity of calcification
  4. Severe mitral regurgitation (>2+)
  5. Presence of mitral bioprosthesis
  6. Presence of previously implanted aortic bioprosthesis
  7. Presence of prosthetic ring
  8. Anatomy NOT appropriate for transfemoral implant due to the size, disease and degree of calcification or tortuosity of the aorta or ilio-femoral arteries
  9. Thoracic (TAA) or abdominal (AAA) aortic aneurysm
  10. Presence of endovascular stent graft for treatment of TAA or AAA
  11. Trans-oesophageal echocardiogram (TEE) is contraindicated
  12. Evidence of intra-cardiac mass, thrombus or vegetation
  13. Severe ventricular dysfunction with ejection fraction < 20%
  14. Any percutaneous intervention, except for balloon valvuloplasty (BAV) within 1 month prior to implant procedure
  15. Acute Myocardial Infarction within 1 month prior to implant procedure
  16. Previous TIA or stroke within 3 months prior to implant procedure
  17. Active ulcer or gastrointestinal (GI) bleeding within 3 months prior to implant procedure
  18. Any scheduled surgical or percutaneous procedure to be performed prior to 30 day visit
  19. Severe coagulation conditions
  20. Refusal of blood transfusions
  21. Systolic pressure <80mmHg, cardiogenic shock, need for inotropic support or IABP
  22. Hypertrophic cardiomyopathy with or without obstruction
  23. Active bacterial endocarditis or other active infections
  24. Hepatic failure (> Child B)
  25. Chronic renal dysfunction with serum creatinine > 2.5 mg/dL or renal dialysis
  26. Refusal of surgery
  27. Severe COPD requiring home oxygen
  28. Neurological disease severely affecting ambulation or daily functioning, or dementia
  29. Life expectancy < 12 months due to non-cardiac co-morbid conditions
  30. Inability to tolerate anticoagulation therapy
  31. Contraindication to contrast media or allergy to nickel
  32. Currently participating in an investigational drug or another device study
  33. Non-valvular aortic stenosis
  34. Non-calcific acquired aortic stenosis

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): NCT02909556


Locations
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Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
Germany
Kerckhoff-Klinik Forschungsgesellschaft mbH
Bad Nauheim, Germany, 61231
Johannes Hospital
Dortmund, Germany
Universitätsklinikum Halle - Universitätsklinik und Poliklinik für Herzchirurgie
Halle (Saale), Germany, 06120
Universitäres Herzzentrum Hamburg - Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, Germany, 20246
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Deutsches Herzzentrum München
München, Germany, 80636
Universitätsklinik Regensburg
Regensburg, Germany, 93053
Switzerland
Luzerner Kantonsspital
Luzern, Switzerland, 6000
Sponsors and Collaborators
Symetis SA
Investigators
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Principal Investigator: Helge Möllmann, Prof. Klinik für Innere Medizin - St.-Johannes-Hospital - Dortmund, Germany
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Responsible Party: Symetis SA
ClinicalTrials.gov Identifier: NCT02909556    
Other Study ID Numbers: 2016-01
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The data and study protocol for this clinical trial may be made available to other researchers in accordance with the Boston Scientific Data Sharing Policy (http://www.bostonscientific.com/en-US/data-sharing-requests.html)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston Scientific Corporation ( Symetis SA ):
Transcatheter Aortic Valve Replacement
TAVI
Transcatheter Aortic Valve Implant
Transfemoral access
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction