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CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System

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: NCT03454360
Recruitment Status : Terminated (Sponsor business decision unrelated to product safety or efficacy.)
First Posted : March 5, 2018
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation ( Symetis SA )

Brief Summary:

The purpose of this registry is to collect specific health and patient data to identify more precisely the patient population undergoing TA aortic valve replacement with the ACURATE neo™ Aortic biprosthesis and ACURATE neo™ TA Transapical Delivery System.

Safety and efficacy data will be collected to support the commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population.

As per IFU, the ACURATE neo™ and its ACURATE neo™ TA Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement using transapical access in patients presenting with severe aortic valve stenosis.


Condition or disease Intervention/treatment
Aortic Stenosis Device: ACURATE neo™ Aortic Bioprosthesis

Detailed Description:
The Primary Objective of this post-market registry is to collect specific health and patient characteristics to understand the indication for TA-TAVI and to further evaluate the safety and performance of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population, consisting of 200 consented patients.

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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Collection of Specific Health And Patient Related Criteria Used to Select traNsapical TAVI Treatment and correspondinG outcomEs: CHANGE Neo™ TA Registry
Actual Study Start Date : February 6, 2018
Actual Primary Completion Date : April 30, 2020
Actual Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: ACURATE neo™ Aortic Bioprosthesis
    TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.
    Other Name: ACURATE neo™ TA Delivery System


Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 30 days ]
    the rate of all-cause mortality as measured at 30-days


Secondary Outcome Measures :
  1. Safety and performance data will be collected to support the commercial use of the ACURATE neo ™ Aortic Bioprosthesis and ACURATE neo™ TA Transapical Delivery System in a specific TA population. [ Time Frame: Procedure to Discharge, 30 days and 12-months ]

    Clinical events as defined per VARC 2 consensus document at procedure:

    All cause mortality; Stroke; Myocardial Infarction; Bleeding complication; Acute kidney injury; Vascular complication; Conduction disturbances and arrhythmia; Other TAVI-related complications


  2. Procedural Success [ Time Frame: Procedure to 24-hours ]
    Defined as absence of intra-procedure mortality (procedure to 24H) AND 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 implanted aortic bioprosthesis (valve-in-valve or ectopic deployment) or if a surgical aortic valve replacement is required to correct a severe aortic regurgitation or procedure complication. The procedure can be considered as success despite the presence of residual aortic regurgitation, which may be due to the anatomic configuration of the annulus or a calcific valvular annulus.

  3. Device Success [ Time Frame: Post-procedure to Discharge. ]

    Defined as;

    • Absence of intra-procedure mortality (procedure to 24H) AND,
    • Correct positioning (placement in the annulus with no impairment of aortic bioprosthesis function) of a single prosthetic heart valve into the proper anatomical location AND,
    • Intended performance of the prosthetic heart valve assessed prior to discharge per local standard of care and defined as:

      • No prosthesis-patient mismatch (EAOi >0.85 cm2/m2 or EAOi >0.7 cm2/m2 for BMI ≥30 kg/m2) ) AND,
      • Mean aortic valve gradient <20mmHg or peak velocity < 3 m/s AND,
      • No moderate or severe prosthetic valve regurgitation.

    For echo parameters for the performance assessment, a pre-discharge echo examination should be performed as per local standard of care. If echo parameter pre-discharge is missing, any echo parameter within 45 days post-procedure may be used.


  4. VARC 2 Composite Safety [ Time Frame: 30-days ]

    Defined as:

    • All-cause mortality
    • All stroke
    • Life-threatening bleeding
    • Acute Kidney Injury- Stage 2 or 3
    • Coronary Artery Obstruction requiring intervention
    • Major Vascular Complications
    • Valve-related dysfunction requiring repeat procedure

  5. Functional improvement as per NYHA Functional Classification [ Time Frame: from baseline to, discharge, 30-days and 12-months follow-up. ]
    Change on NYHA Class between baseline and different follow-up

  6. Improvement of EOA and mean Trans-prosthetic gradient [ Time Frame: from baseline to discharge, 30- days and 12 months follow-up ]
    If the echo parameter pre-discharge is missing to assess the intended performance, any echo parameter data within 45-days post procedure may be used for the missing values;

  7. Total Aortic Regurgitation [ Time Frame: post-procedure, prior to discharge, at 30-days and 12-months follow-up; ]
    Change on Aortic Regurgitation over time at follow-up



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects with severe aortic stenosis, for whom the transapical access is the most suitable approach as per heart-team consensus, who signed the Informed Consent Form (ICF) approved by the Independent Ethics Committee (IEC), and are deemed to be candidates to undergo transcatheter aortic valve implantation with the ACURATE neo™ Aortic Bioprosthesis and its Transapical Delivery System as per clinical practice at each participating site
Criteria

Inclusion criteria:

  • Symptomatic patients with severe aortic stenosis;
  • Institution heart team determines that aortic valve replacement ACURATE neoTM device using its transapical delivery system is appropriate;

Exclusion criteria:

- Patients unable or unwilling to give inform consent;


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): NCT03454360


Locations
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Germany
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
Herz-und Gefäß-Kilink GmbH
Bad Neustadt an der Saale, Germany, 97616
Krankenhausbetriebgesellschaft
Bad Oeynhausen, Germany, D-32545
BG Klinik Bergmannsheil
Bochum, Germany, 44789
Universitätsklinikum Frankfurt- Klinik für Thorax, Herz und thorakale Gefæßchirurgie
Frankfurt, Germany, 60590
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Freiburg, Germany, 79106
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Herzzentrum Leipzig
Leipzig, Germany, 04289
Deutsches Herzzentrum München
München, Germany, 80636
Universitätsklinikum Regensburg
Regensburg, Germany, 93053
Sponsors and Collaborators
Symetis SA
Investigators
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Principal Investigator: Michael Hilker, Prof.Dr.med Universitätsklinikum Regensburg
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Responsible Party: Symetis SA
ClinicalTrials.gov Identifier: NCT03454360    
Other Study ID Numbers: 2016-03
First Posted: March 5, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 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 ):
TAVI
Transcatheter Aortic Valve Replacement
Transcatheter Aortic Valve
Transapical Access
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction