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Trial registered on ANZCTR


Trial ID
ACTRN12614000406606
Ethics application status
Approved
Date submitted
27/03/2014
Date registered
14/04/2014
Date last updated
13/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Vado 'trademark' Steerable Sheath System; A Safety and Performance Study to evaluate access to the Pulmonary Veins in the Treatment of Paroxysmal and Persistent Atrial Fibrillation
Scientific title
Steerable Sheath to access Pulmonary Veins in treatment of Paroxysmal Atrial Fibrillation (PAF) and Persistent Atrial Fibrillation at Christchurch Hospital
Secondary ID [1] 284347 0
None
Universal Trial Number (UTN)
U1111-1155-0314
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
paroxysmal atrial fibrillation 291500 0
atrial fibrillation 291539 0
Condition category
Condition code
Cardiovascular 291870 291870 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Vado is a steerable sheath that will be inserted into the femoral vein and be advanced into the right atrium to the septum. The sheath will be positioned so that an ablation catheter can be inserted and advanced across the septum to ablate the pulmonary veins. Catheter and sheath will be removed after ablation. The procedure is approximately one hour and patient will go home next day. Follow up at discharge only.
Intervention code [1] 289072 0
Treatment: Devices
Comparator / control treatment
Single group study all patients will receive the same treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291790 0
1. Safety: Absence of adverse device related events at release from hospital post procedure per institutional standard of care.
Possible adverse events include hematoma, infection, access site complications. Outcome will be assessed by ability of ablation catheter to be inserted and retrieved through the sheath visualized fluoroscopically.
Timepoint [1] 291790 0
Outcome will be assessed during the procedure after sheath insertion and withdrawal as seen fluoroscopically. Discharge is another assessment for serious adverse events.
Primary outcome [2] 291825 0
2. Performance: Steerability and Positioning to facilitate catheter placement as seen fluoroscopically and by ability to visualize navigation of ablation catheter to the pulmonary veins.
Timepoint [2] 291825 0
Intra procedurally the ablation will be performed. Sheath will be visualized fluoroscopically during the procedure.
Secondary outcome [1] 307549 0
1. Safety : Hemostasis and ability to visualize the steerable sheath. Visualize fluoroscopically and cineangiogram to show placement. Withdrawal of the sheath and hemostasis of the femoral venous entry and exit site.
Timepoint [1] 307549 0
During the conclusion of the procedure an assessment of the access site by visualizing no bleeding or oozing and good hemostasis of the access site.
Secondary outcome [2] 307621 0
2. Safety: Safe event free Insertion of the steerable sheath system in the femoral vein as seen on fluoroscopy and cineangiogram.
Timepoint [2] 307621 0
During the procedure the sheath will be visualized on fluoro.

Eligibility
Key inclusion criteria
1.Suitable candidate for intra-cardiac mapping for
arrhythmias with documented PAF defined by HRS criteria.
2. Eighteen (18) to eighty (80) years of age
3. Signed Informed Consent
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Intracardiac thrombus, tumor or other abnormality that precludes
catheter introduction and placement
2. Severe cerebrovascular disease or history of cerebrovascular event
within one (1) month
3. Patients with severely impaired kidney function as measured by a
Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29.
4. Active gastrointestinal bleeding, infection or fever (> 100.5/38C)
5. Severe co morbidity or Short life expectancy (<1 year) due to other illnesses such as cancer, pulmonary, hepatic or renal disease
6. Structural heart disease of clinical significance including
a. Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing
b.Stable/unstable angina or ongoing myocardial ischemia
c.Myocardial infarction (MI) within three months of enrollment
d.Aortic or mitral valve disease > Grade II
e. Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
7. Enrollment in any other ongoing arrhythmia study protocol
8. Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
9. Active infection or sepsis
10. Female patient is pregnant or lactating
11. Untreatable allergy to contrast media
12. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
13. History of blood clotting (bleeding or thrombotic) abnormalities
14. Known sensitivities to heparin or warfarin
15. Severe COPD (identified by an FEV1 <1)


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)
Individual subjects will be studied during mapping and ablation procedures and followed until release from hospital post procedure per institutional standard of care.
study involves the sequential enrollment of patients that meet both inclusion/exclusion criteria. It is intended that the Vado Steerable Sheath will be used as part of standard clinical workflow procedures, with no procedural deviations relative to other procedures requiring steerable sheaths.
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
Statistical methods / analysis
The safety and performance of the device will be assessed relative to the study objectives. Five (5) patients will be treated.All study results will be analyzed using widely accepted statistical or graphical software. Patient data listings and tabular and graphical presentations of baseline and operative characteristics and outcome results will be provided. Additionally, all adverse events will be summarized by type of event, severity, relationship to the device and/or procedure, and timing of event relative to the procedure date. Data will be evaluated to published literature on currently available steerable sheaths.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5931 0
New Zealand
State/province [1] 5931 0
Christchurch

Funding & Sponsors
Funding source category [1] 288981 0
Commercial sector/Industry
Name [1] 288981 0
Kalila Medical
Address [1] 288981 0
745 Camden Ave.
Campbell, California 95008
Country [1] 288981 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Kalila Medical
Address
745 Camden Ave.
Campbell, California 95008
Country
United States of America
Secondary sponsor category [1] 287660 0
None
Name [1] 287660 0
Address [1] 287660 0
Country [1] 287660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290793 0
Health and Disability Ethics Committees
Ethics committee address [1] 290793 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
Ethics committee country [1] 290793 0
New Zealand
Date submitted for ethics approval [1] 290793 0
28/03/2014
Approval date [1] 290793 0
24/04/2014
Ethics approval number [1] 290793 0
14/STH/37/AM01

Summary
Brief summary
To confirm the safe insertion of a steerable sheath in the venous system to direct and perform positioning, and removal of the ablation catheter. Ablation is performed when patients have arrhythmias which cause shortness of breath and can be if not treated life threatening. Acute safety evaluation at end of procedure as evidenced by absence of device related adverse events. Our sheath will be used in usual manner as current available steerable sheaths.

Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 47294 0
Dr Ian Crozier
Address 47294 0
Christchurch Hospital
Department of Cardiology
Private Bag 4710
Christchurch 8140
Country 47294 0
New Zealand
Phone 47294 0
+6433641096
Fax 47294 0
+6433786378
Email 47294 0
ian.crozier@cdhb.health.nz
Contact person for public queries
Name 47295 0
Ms Catherine Cruickshank
Address 47295 0
Christchurch Hospital
Department of Cardiology
Private Bag 4710
Christchurch 8140
Country 47295 0
New Zealand
Phone 47295 0
+6433641096
Fax 47295 0
+6433786378
Email 47295 0
catherine.cruickshank@cdhb.health.nz
Contact person for scientific queries
Name 47296 0
Dr Ian Crozier
Address 47296 0
Christchurch Hospital
Department of Cardiology
Private Bag 4710
Christchurch 8140
Country 47296 0
New Zealand
Phone 47296 0
+6433641096
Fax 47296 0
Email 47296 0
ian.crozier@cdhb.health.nz