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

Not Applicable

Recruiting

• Conditions: Severe Aortic Stenosis; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12616000064404
• Lead Sponsor: Reid Healthcare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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
requirement
10. Study participant cannot comply with study requirements, including follow-up visits and tests

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is incidence of all-cause mortality. [At 30 days post surgery.]