ACURATE neo Trademark Aortic Bioprosthesis for Implantation using the ACURATE TF Trademark Transfemoral Delivery System in Patients with Severe Aortic Stenosis in an Australian Population

Reid Healthcare0 sites100 target enrollmentJanuary 21, 2016

Overview

No summary available.

Registry

who.int

Start Date

January 21, 2016

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Reid Healthcare

•The inclusion criteria are as below:
•1\. Study participant is 18 years or older
•2\. STS score is greater than or equal to 4; and/or heart team (at least one interventional cardiologist and one cardiac surgeon) agree on eligibility including assessment that TAVR is appropriate.
•3\. Study participant has severe aortic stenosis with mean gradient is greater than or equal to 40mmHg or jet velocity greater than or equal to 4\.0 m/s and/or an initial aortic valve area (AVA) of less than or equal to 0\.8 cm2 or indexed EOA is less than 0\.5 cm2/m2\.
•4\. Study participant is symptomatic from his/her aortic valve stenosis, as demonstrated by
•New York Heart Association (NYHA) Functional Class II or greater.
•5\. Study participant is willing to participate in the study, provides signed Informed
•Consent/Data Authorization Form and authorizes the sharing of data in the study
•6\. The study participant and treating physician agree the study participant will return for all
•required post\-procedure follow\-up visits

•The exclusion criteria are as below:
•1\. Native aortic annulus size less than 21mm or greater than 27mm
•2\. Evidence of an acute myocardial infarction less than or equal to 1 month before the intended treatment
•3\. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
•4\. Recent (within 3 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
•5\. Severe dementia (as evidenced in medical history)
•6\. Estimated life expectancy is less than 12 months
•7\. Currently participating in an investigational drug or another device trial (excluding registries)
•8\. Active bacterial endocarditis within 6 months of the intended TAVR procedure
•9\. Pregnancy or intent to become pregnant prior to completion of all protocol follow\-up