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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02306226
Other study ID # 2013-05
Secondary ID
Status Completed
Phase
First received September 2, 2014
Last updated March 15, 2018
Start date September 2014
Est. completion date April 2017

Study information

Verified date March 2018
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date April 2017
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Symetis SA

Outcome

Type Measure Description Time frame Safety issue
Other Rate of clinical endpoints (VARC 2) Mortality
Stroke
Myocardial infarction
Bleeding complication
Acute kidney injury
Vascular complication
Conduction disturbances and arrhythmia
Other TAVI-related complications
Procedure, 7 days or discharge (whichever occurs first), 30 days, 12 months
Other Procedural success 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
Post-implantation
Other Device success 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
7 days or discharge (whichever occurs first), 12 months
Other Functional improvement from baseline as per NYHA Functional Classification at 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up 7 days or discharge (whichever occurs first), 30 days and 12 months follow-up
Primary Rate of all-cause mortality 30 days
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