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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 )

Tracking Information
First Submitted Date December 8, 2014
First Posted Date May 8, 2017
Last Update Posted Date March 19, 2018
Study Start Date November 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 3, 2017)
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)
Official Title Not Provided
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Symptomatic Aortic Stenosis
Intervention 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
Study Groups/Cohorts 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.
Intervention: Device: ACURATE TA™ Transapical Aortic Bioprosthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 3, 2017)
250
Original Actual Enrollment Same as current
Actual Study Completion Date November 2013
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Germany,   Italy,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03143686
Other Study ID Numbers 2011-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Boston Scientific Corporation ( Symetis SA )
Study Sponsor Symetis SA
Collaborators Not Provided
Investigators Not Provided
PRS Account Boston Scientific Corporation
Verification Date March 2018