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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 )

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

Condition or disease
Aortic Stenosis

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Symetis ACURATE Neo™ Valve Implantation Using TransFemoral Access: SAVI TF Registry
Study Start Date : September 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : April 2017





Primary Outcome Measures :
  1. Rate of all-cause mortality [ Time Frame: 30 days ]

Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


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): NCT02306226


Sponsors and Collaborators
Symetis SA
Investigators
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Principal Investigator: Helge Möllmann, Prof. Kerckhoff Klinik
Additional Information:

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Responsible Party: Symetis SA
ClinicalTrials.gov Identifier: NCT02306226    
Other Study ID Numbers: 2013-05
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by Boston Scientific Corporation ( Symetis SA ):
TAVI
Aortic stenosis
Transcatheter aortic valve replacement
Transcatheter aortic valve implantation
Transfemoral access
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction