Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000064404
Ethics application status
Approved
Date submitted
8/12/2015
Date registered
21/01/2016
Date last updated
5/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 288085 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Aortic Stenosis 296952 0
Condition category
Condition code
Cardiovascular 297197 297197 0 0
Other cardiovascular diseases
Surgery 297226 297226 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 293397 0
Treatment: Devices
Intervention code [2] 293414 0
Treatment: Surgery
Comparator / control treatment
No control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297058 0
The primary endpoint is incidence of all-cause mortality.
Timepoint [1] 297058 0
At 30 days post surgery.
Secondary outcome [1] 319391 0
1 Mortality,
Timepoint [1] 319391 0
Assessed at 7 days or discharge (whichever occurs first), and at 12 months
follow-up.
Secondary outcome [2] 319465 0
2. Stroke, Assessed by Clinical diagnosis and using neurological assessment tools as required. i.e. Neurologist, Neuro imaging procedures - MRI,and or CT scan or cerebral angiography, lumbar puncture.
Timepoint [2] 319465 0
Assessed at 7 days or discharge (whichever occurs first), 30 days and at 12 months
follow-up.
Secondary outcome [3] 319931 0
3.Myocardial Infarction (assessed by ECG, Echocardiography and Angiography)
Timepoint [3] 319931 0
: Angiography at procedure, Echocardiography at procedure (immediately post implant), discharge/7days (whichever occurs first) , 30 days, 12 months.
Secondary outcome [4] 319932 0
4.Bleeding complications (assessed and reported by Cardiologist or Surgeon in Operation notes)
Timepoint [4] 319932 0
assessed at procedure, 7 days or discharge, 30 days and at 12 months
Secondary outcome [5] 319933 0
5. Acute kidney injury (assessed by blood analysis),
Timepoint [5] 319933 0
assessed at procedure, 7 days or discharge, 30 days and at 12 months
Secondary outcome [6] 319934 0
6. Vascular complication( assessed by observation under fluoroscopy/angiography/Echocardiography and recording of vital signs and blood loss by Cardiologist/Surgeon in operational notes)
Timepoint [6] 319934 0
assessed at procedure, 7 days or discharge, 30 days and at 12 months:
Secondary outcome [7] 319935 0
7. Conduction disturbances and arrhythmia(assessed by ECG)
Timepoint [7] 319935 0
assessed at procedure, 7 days or discharge, 30 days and at 12 months:
Secondary outcome [8] 319936 0
Functional improvement from baseline as per NYHA Functional Classification.
Timepoint [8] 319936 0
assessed at procedure, 7 days or discharge (whichever occurs first), 30 days and at 12 months follow-up.
Secondary outcome [9] 319937 0
Device success defined as: ACURATE neo trademark implanted in intended location (correct positioning assessed by Echocardiography), Absence of procedural mortality, Mean gradient < 20mmHg or 3m/s ( assessed by Echocardiography).
Timepoint [9] 319937 0
at 7 days or discharge (whichever occurs first), 30 days and at 12 months follow-up
Secondary outcome [10] 319938 0
No prosthesis - study participant mismatch (assessed by review of study records).
Timepoint [10] 319938 0
assessed at procedure, 7 days or discharge, 30 days and at 12 months:
Secondary outcome [11] 319939 0
No moderate or severe prosthetic valve regurgitation assessed by Echocardiography
Timepoint [11] 319939 0
assessed at procedure, 7days/discharge (whichever occurs first), 30 days and 12 months.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2016
Actual
12/04/2016
Date of last participant enrolment
Anticipated
29/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7214 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 7215 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 14979 0
4032 - Chermside
Recruitment postcode(s) [2] 14980 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 292514 0
Commercial sector/Industry
Name [1] 292514 0
Reid Healthcare
Country [1] 292514 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Reid Healthcare
Address
1/71 Centennial Circuit
Byron Bay, NSW.
2481
Country
Australia
Secondary sponsor category [1] 291222 0
None
Name [1] 291222 0
None
Address [1] 291222 0
None
Country [1] 291222 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293995 0
RPA Hospital
Ethics committee address [1] 293995 0
Ethics committee country [1] 293995 0
Australia
Date submitted for ethics approval [1] 293995 0
Approval date [1] 293995 0
12/08/2015
Ethics approval number [1] 293995 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62018 0
Prof Martin Ng
Address 62018 0
Dept of Cardiology
Level 6
Royal Prince Alfred Hospital
Missenden Road,
Camperdown
New South Wales 2050
Country 62018 0
Australia
Phone 62018 0
+ 61 2 9515 8723
Fax 62018 0
Email 62018 0
[email protected]
Contact person for public queries
Name 62019 0
Mrs Joanne White
Address 62019 0
Reid Healthcare
1/71 Centennial Circuit
Byron Bay, NSW
2481
Country 62019 0
Australia
Phone 62019 0
+ 61 2 6685 8789
Fax 62019 0
Email 62019 0
[email protected]
Contact person for scientific queries
Name 62020 0
Mrs Joanne White
Address 62020 0
Reid Healthcare
1/71 Centennial Circuit
Byron Bay, NSW.
2481
Country 62020 0
Australia
Phone 62020 0
+61 2 6685 8789
Fax 62020 0
Email 62020 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.