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Trial registered on ANZCTR


Registration number
ACTRN12618001923257
Ethics application status
Approved
Date submitted
22/11/2018
Date registered
27/11/2018
Date last updated
27/11/2018
Date data sharing statement initially provided
27/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Shockwave Medical Transfemoral Aortic Valve Lithotripsy (TAVL) System to treat symptomatic, severe calcified aortic stenosis (TAVL FIM IV)
Scientific title
Safety and Feasibility of the Shockwave Medical Transfemoral Aortic Valve Lithotripsy (TAVL) System to treat symptomatic, severe calcified aortic stenosis (TAVL FIM IV)
Secondary ID [1] 296693 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
TAVL FIM IV
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Calcified Aortic Stenosis 310539 0
Condition category
Condition code
Cardiovascular 309249 309249 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with severe calcified aortic stenosis fulfilling the inclusion / exclusion criteria will be treated once with the Shockwave Medical Transfemoral Aortic Valve Lithotripsy (TAVL) System. This system delivers lithotripsy energy waves via a proprietary catheter to calcified leaflets of the aortic valve in one treatment procedure. Up to 150 pulses (via up to 10 cycles of 15 pulses over 10 seconds per cycle) may be delivered (if required). The therapy is delivered in a single procedure administered under general anaesthesia in a cardiac catheterisation laboratory by an interventional cardiologist. The procedure will take approximately 2 hours. Efficacy is measured intra-procedurally by changes in aortic valve function determined by echocardiography.
Intervention code [1] 313006 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308224 0
Major adverse cardiac and cerebrovascular events (MACCE) defined as a composite of all-cause mortality, myocardial infarction, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 30 days post procedure assessed by review of adverse events in patient medical records.
Timepoint [1] 308224 0
30 days post procedure
Primary outcome [2] 308225 0
Mean aortic valve pressure gradient measured by echocardiography at 30 days post procedure
Timepoint [2] 308225 0
30 days post procedure
Secondary outcome [1] 354280 0
Device success defined as successful catheter delivery, delivery of lithotripsy energy, and removal of catheter.
Timepoint [1] 354280 0
At time of TAVL procedure
Secondary outcome [2] 354281 0
Major adverse cardiac and cerebrovascular events (MACCE) defined as a composite of all-cause mortality, myocardial infarction, stroke, life-threatening and major bleeding events, stage 2 or 3 acute kidney injury, or major vascular complications at 3, 6 and 12 months. MACCE is assessed by a review of patient records and evaluation of patient by investigators at follow up.
Timepoint [2] 354281 0
At 3, 6 and 12 months
Secondary outcome [3] 354282 0
Neurological assessment by Modified Rankin Score at 30 days, 3, 6 and 12 months
Timepoint [3] 354282 0
30 days, 3, 6 and 12 months
Secondary outcome [4] 354283 0
Echocardiographical Dimensionless index at pre- and post-procedure
Timepoint [4] 354283 0
Pre and Post TAVL Procedure
Secondary outcome [5] 354284 0
Mean aortic valve pressure gradient as measured by echocardiography at 3, 6 and 12 months
Timepoint [5] 354284 0
At 3, 6 and 12 months
Secondary outcome [6] 354285 0
Aortic valve area measured by echocardiography data.
Timepoint [6] 354285 0
At 30 days, 3, 6 and 12 months
Secondary outcome [7] 354286 0
SF-12 Health Survey to assess Quality of Life
Timepoint [7] 354286 0
At 30 days, 3, 6 and 12 months
Secondary outcome [8] 354287 0
New York Heart Association (NYHA) classification at 30 days, 3, 6 and 12 months
Timepoint [8] 354287 0
At 30 days, 3, 6 and 12 months
Secondary outcome [9] 354288 0
Six-minute walk test (6MWT) at 30 days, 3, 6 and 12 months
Timepoint [9] 354288 0
At 30 days, 3, 6 and 12 months
Secondary outcome [10] 354319 0
Aortic Regurgitation measured by echocardiography data.
Timepoint [10] 354319 0
At 30 days. 3, 6 and 12 months
Secondary outcome [11] 354320 0
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [11] 354320 0
At 30 days, 3, 6 and 12 months

Eligibility
Key inclusion criteria
1. Age greater than 18 years
2. Senile degenerative aortic valve stenosis with the following assessed by echocardiogram performed within 60 days of the procedure: a. Mean gradient greater than 40 mmHg or jet velocity greater than 4.0 m/s, and b. An initial aortic valve area (AVA) of less than or equal to 0.8 cm2 or indexed effective orifice area (EOA) less than 0.5 cm2/m2
3. Symptomatic aortic valve stenosis with NYHA Class greater than Class II
4. Patient is able and willing to comply with all assessments in the study
5. Patient or patient’s legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form
6. Patient approved for inclusion by Physician Screening Committee
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Bicuspid aortic valve
2. Rheumatic valve disease
3. Aortic valve insufficiency greater than 2+
4. Prior aortic valve surgery or endovascular procedure
5. Left ventricular ejection fraction (LVEF) less than 30%
6. Acute myocardial infarction within 30 days
7. Stroke or transient ischemic attack (TIA) within 12 months
8. Life expectancy less than one (1) year
9. High risk for stroke in the judgement of the investigator
10. History of endocarditis
11. Active infection
12. Need for emergency surgery for any reason
13. Known hypersensitivity or contraindication to anticoagulation, contrast or device components.
14. Severe vascular disease that would preclude safe access
15. Planned endovascular or surgical procedures within 30 days of index procedure with the exception of clinically-driven coronary revascularization
16. Patient is pregnant or nursing
17. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The study is not powered to show statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/12/2018
Actual
Date of last participant enrolment
Anticipated
6/12/2019
Actual
Date of last data collection
Anticipated
4/12/2020
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 12514 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 12515 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 12517 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 24895 0
3168 - Clayton
Recruitment postcode(s) [2] 24896 0
2050 - Camperdown
Recruitment postcode(s) [3] 24898 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 301272 0
Commercial sector/Industry
Name [1] 301272 0
Shockwave Medical Inc.
Country [1] 301272 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Shockwave Medical Inc.
Address
Shockwave Medical, Inc.
48501 Warm Springs Blvd.,
Suite #108
Fremont, CA 94539 USA
Country
United States of America
Secondary sponsor category [1] 300916 0
None
Name [1] 300916 0
Address [1] 300916 0
Country [1] 300916 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302014 0
Monash Health
Ethics committee address [1] 302014 0
Research Support Services
Monash Health
Level 2, I Block Monash Medical Centre
246 Clayton Road
Clayton Victoria 3168
Ethics committee country [1] 302014 0
Australia
Date submitted for ethics approval [1] 302014 0
13/04/2018
Approval date [1] 302014 0
12/07/2018
Ethics approval number [1] 302014 0
18-0000-228A

Summary
Brief summary
The purpose of this study is to evaluate the safety and feasibility of the Shockwave Medical Lithotplasty System for patients with severe calcified aortic stenosis,

Who is it for?
You may be eligible for this study if you are aged 18 or older and have severe calcified aortic stenosis.

Study details
All participants will receive TAVL treatment during a procedure under general anaesthesia in a cardiac catheterisation laboratory. All participants will be followed-up according to the protocol specific endpoints. Patients will undergo diagnostic tests such as CT scan, echocardiography (both transthoracic and oesophageal) , laboratory (blood tests) and undertake several questionnaires as a part of the clinical trial.

It is hoped that this research will provide information into the non-surgical treatments of severe aortic stenosis thereby providing future non-surgery related options for the disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55110 0
A/Prof Robert Whitbourn
Address 55110 0
Cardiac Investigations Unit
St Vincent’s Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065

Country 55110 0
Australia
Phone 55110 0
+61 03 9231 4441
Fax 55110 0
Email 55110 0
[email protected]
Contact person for public queries
Name 55111 0
Matthew Godden
Address 55111 0
Australian Healthcare Solutions Pty Ltd.
Level 1 / 424 Burke Road
Camberwell, VIC 3124
Country 55111 0
Australia
Phone 55111 0
+61 400 007 127
Fax 55111 0
Email 55111 0
[email protected]
Contact person for scientific queries
Name 55112 0
Beaux Alexander
Address 55112 0
Shockwave Medical
48501 Warm Springs Blvd.,
Suite # 108
Fremont, CA 94539 USA
Country 55112 0
United States of America
Phone 55112 0
+ 1 (707) 490-6107
Fax 55112 0
Email 55112 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient data treated as confidential. Grouped data to be published


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.