Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

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: NCT03143686
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation ( Symetis SA )

Brief Summary:
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

Condition or disease Intervention/treatment
Symptomatic Aortic Stenosis Device: ACURATE TA™ Transapical Aortic Bioprosthesis

Detailed Description:
A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.

Layout table for study information
Study Type : Observational
Actual Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : November 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : November 2013


Group/Cohort Intervention/treatment
ACURATE TA™ Transapical Aortic Bioprosthesis
The first two hundred and fifty (250) patients in whom the commercial, or CE Mark, ACURATE TATM Transapical Aortic Bioprosthesis is implanted.
Device: ACURATE TA™ Transapical Aortic Bioprosthesis
ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.
Other Name: ACURATE TA™ Transapical Aortic Bioprosthesis and delivery System




Primary Outcome Measures :
  1. Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant [ Time Frame: 30 days and 12 Months Follow-up ]

    Rate of major cardiac and cerebrovascular event (MACCE) at 30 days and at 12 months post-implant .

    MACCE defined as All cause mortality, Re-intervention, Myocardial Infarction, or Stroke.



Secondary Outcome Measures :
  1. Procedural Success post-implantation (up to 24 hours after device implantation) [ Time Frame: Post-Implantation (up to 24 hours after device implantation) ]
    Procedural success defined as successful ACURATE TA™ implantation at intended site and adequate device functioning immediately post-implantation and without intra-procedural mortality

  2. Device success at 30 days and 12 Months follow-up [ Time Frame: 30 days and 12 Months follow-up ]
    Device success at 30 day and 12 month follow-up visit defined as adequate functioning of the ACURATE TA™ as confirmed by echocardiography.



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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ACURATE TA™ is approved for use to treat patients with severe aortic stenosis. The registry includes all comer patients following the Instructions For Use.
Criteria

Inclusion Criteria:

  • Patient has severe aortic stenosis
  • Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
  • Patient willing to participate in the study and provides signed EC-approved informed consent
  • The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

  • Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.

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): NCT03143686


Locations
Show Show 17 study locations
Sponsors and Collaborators
Symetis SA
Layout table for additonal information
Responsible Party: Symetis SA
ClinicalTrials.gov Identifier: NCT03143686    
Other Study ID Numbers: 2011-02
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by Boston Scientific Corporation ( Symetis SA ):
Severe symptomatic Aortic Stenosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction