None listed
Conditions
Brief summary
The purpose of this study is to collect and monitor ongoing safety and performance data from commercial use of the ACURATE neo trademark Aortic Bioprosthesis, hereafter referred to as the ACURATE neo trademark, and ACURATE TF trademark Transfemoral Delivery System. The ACURATE neo trademark and its Transfemoral Delivery System are intended for use in minimally invasive, transcatheter aortic valve replacement (TAVR) using transfemoral access in study participants presenting with severe aortic valve stenosis. Note, the ACURATE neo trademark and its Transfemoral Delivery System has been CE Marked and approved for sale in Europe. This study protocol is being implemented in Australia and is equivalent to the post market clinical follow-up plan study protocol developed by Symetis post European certification.
Interventions
A single-arm, multicenter, non-randomized open study that will include up to 100 study participants implanted with ACURATE neo Trademark and its Transfemoral Delivery
System. The study will collect data from study participants treated with the ACURATE neo Trademark and its Transfemoral Delivery System following standard TAVI practice at each participating center. All study participants will be followed to 12 months after the implant procedure. The study is divided into two periods:
1) Implantati
A single-arm, multicenter, non-randomized open study that will include up to 100 study participants implanted with ACURATE neo Trademark and its Transfemoral Delivery System. The study will collect data from study participants treated with the ACURATE neo Trademark and its Transfemoral Delivery System following standard TAVI practice at each participating center. All study participants will be followed to 12 months after the implant procedure. The study is divided into two periods: 1) Implantation procedure (immediately pre-implant to 24 hours post-procedure) 2) Follow-up period (discharge or 7 days, whichever occurs first, at 30 days and at 12 months) Prior to implantation, the Bioprosthesis is carefully loaded onto the Delivery System using aspecially designed loading tool. The Bioprosthesis is inserted into the femoral artery through a compatible introducer sheath and delivered retrograde to the implantation site using the Delivery System. The Bioprosthesis is positioned and deployed over the stenotic, native aortic valve and the Delivery System is then removed. This minimally invasive transcatheter approach is intended to be performed under general or regional anesthesia as per the physician’s standard of practice using sterile technique, with echocardiographic and fluoroscopic guidance for visualization.
Sponsors
Reid Healthcare
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed