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Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry (SAVI TF)

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: NCT02306226
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation ( Symetis SA )

Tracking Information
First Submitted Date September 2, 2014
First Posted Date December 3, 2014
Last Update Posted Date March 19, 2018
Study Start Date September 2014
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2014)
Rate of all-cause mortality [ Time Frame: 30 days ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 28, 2014)
  • Rate of clinical endpoints (VARC 2) [ Time Frame: Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months ]
    • Mortality
    • Stroke
    • Myocardial infarction
    • Bleeding complication
    • Acute kidney injury
    • Vascular complication
    • Conduction disturbances and arrhythmia
    • Other TAVI-related complications
  • Procedural success [ Time Frame: Post-implantation ]
    Procedural success defined as ACURATE neo™ implanted in intended location with:
    • Valve insufficiency < Grade 3
    • Mean aortic gradient < 20 mmHg
    • EOA ≥ 1.0 cm2
    • No valve-in-valve or conversion to surgery performed
    • No intra-procedure mortality
  • Device success [ Time Frame: 7 days or discharge (whichever occurs first), 12 months ]
    Device success as defined as:
    • ACURATE neo™ implanted in intended location
    • No impingement of the mitral valve
    • Normal coronary blood flow
    • Valve insufficiency < Grade 3
    • Mean gradient < 20mmHg
    • EOA ≥ 1.0 cm2
    • No valve-in-valve or conversion to surgery performed
  • Functional improvement from baseline as per NYHA Functional Classification at 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up [ Time Frame: 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry
Official Title Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry
Brief Summary Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device
Detailed Description

The SAVI TF is s single arm, multicenter, non-randomized and open registry. The purpose of this registry is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System.

The ACURATE neo™ and its 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 further evaluate the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in the first 1000 consecutive patients with severe aortic stenosis treated with the newly marketed device.

The secondary objective is to evaluate adverse events and device performance of the newly marketed device.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 12 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population As the ACURATE neo™ is approved for use to treat patients with severe aortic stenosis, the inclusion criteria are broad in order to allow the device to be used in an all-comers population and following the Instructions For Use.
Condition Aortic Stenosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: August 6, 2015)
1000
Original Estimated Enrollment
 (submitted: November 28, 2014)
250
Actual Study Completion Date April 2017
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Patient is included in the registry if eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions for Use
  2. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the registry
  3. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

1. Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System as per the Instructions For Use.

Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Germany
 
Administrative Information
NCT Number NCT02306226
Other Study ID Numbers 2013-05
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
Principal Investigator: Helge Möllmann, Prof. Kerckhoff Klinik
PRS Account Boston Scientific Corporation
Verification Date March 2018