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

• ClinicalTrials.gov Identifier: NCT03143686
• Recruitment Status: Completed
• First Posted: May 8, 2017
• Last Update Posted: March 19, 2018
• Sponsor: Symetis SA
• 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

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

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

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