Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000376145p
Ethics application status
Not yet submitted
Date submitted
20/02/2019
Date registered
11/03/2019
Date last updated
17/02/2020
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the AccessPath™ Transseptal Introducer Sheath used in Patients undergoing catheter ablation to treat Atrial Fibrillation
Scientific title
Safety and Performance of the AccessPath™ Transseptal Introducer Sheath in Percutaneous Intracardiac Access via Transseptal Puncture for patients with Atrial Fibrillation Undergoing Catheter Ablation
Secondary ID [1] 297432 0
None
Universal Trial Number (UTN)
U1111-1228-9661
Trial acronym
SAFE ACCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 311645 0
Condition category
Condition code
Cardiovascular 310269 310269 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
an electrophysiologist will insert the transseptal introducer sheath and dilator assembly into the vein over a standard guidewire and advanced until the sheath tip is in the SVC. A transseptal needle is flushed as in normal standard of care and inserted into the sheath assembly once an appropriate angle is set under fluoroscopy with the access path. The access path assists by setting the angle to cross the septum. The transseptal needle is then pushed across the interatrial septum under fluoroscopy. This use is no different from normal standard of care for transseptal access.
Intervention code [1] 313900 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319162 0
Use of the Access Path sheath during catheter based treatment of atrial fibrillation by ablation and complete the procedure with no adverse device or procedure events at completion of procedure and discharge per per institutional standard of care. Adverse events such as access groin hematomas or excessive bleeding events and will be tracked using data case report forms collected post procedurally and until discharge measured by safe event free completion of the procedure and removal of the device. Data will be monitored for accuracy and reported in a investigational summary report.
Timepoint [1] 319162 0
intra procedure, post procedure and discharge
Primary outcome [2] 319163 0
Insertion of the transseptal introducer sheath to assist in selecting the location in the septum to cross under fluoroscopy. Introducer sheath will be used no more than two times to achieve and reach a successful performance outcome. This data will be collected on study approved data case report forms and source documentation will include fluoro images collected post procedurally from the investigator.
Timepoint [2] 319163 0
Intraprocedure
Secondary outcome [1] 367148 0
ability to visualize the sheath for precise positioning under fluoroscopy and images stored as source documentation as well as data case report forms collected from the study coordinator.
Timepoint [1] 367148 0
intraprocedure only
Secondary outcome [2] 367320 0
ability to advance the sheath across the fossa ovalis under fluoroscopic guidance. Images will be collected post procedure as source data and stored. Data results input on data case report forms filled out by the study coordinator.
Timepoint [2] 367320 0
Intraprocedure
Secondary outcome [3] 367321 0
safe free insertion of the sheath under fluoroscopic guidance. Confirmation will be saved by images stored post procedure and collected on data case report forms from the study coordinator.
Timepoint [3] 367321 0
intraprocedural and discharge
Secondary outcome [4] 367788 0
safe free retrieval of the sheath out of the body under fluoroscopic guidance. Images of this under fluoroscopy will be stored as source data. Data will also be collected on case report forms post procedure filled out by the study coordinator.
Timepoint [4] 367788 0
intraprocedure

Eligibility
Key inclusion criteria
suitable candidate scheduled for percutaneous transseptal access for atrial fibrillation ablation procedures
Eighteen to eighty years of age
Signed informed consent
Minimum age
18 Years
Maximum age
80 Years
Sex
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
creatinine of > 150 ml/min.
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. Stable/unstable angina or ongoing myocardial ischemia
b. Myocardial infarction (MI) within three months of enrollment
c. Aortic or mitral valve disease > Grade II
d. 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. Female patient is pregnant or lactating
8. Untreatable allergy to contrast media
9. Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
10. History of blood clotting (bleeding or thrombotic) abnormalities
11. Known sensitivities to heparin or warfarin

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The safety and performance of the device will be assessed relative to the study objectives. All study results will be analyzed using widely accepted statistical or graphical software. Data will be evaluated to published literature on currently available steerable sheaths. No statistical analysis will be performed on this small sample size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/04/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 21292 0
New Zealand
State/province [1] 21292 0
Christchurch

Funding & Sponsors
Funding source category [1] 302001 0
Commercial sector/Industry
Name [1] 302001 0
CardioPathways, Inc.
Country [1] 302001 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
CardioPathways, Inc.
Address
11107 Roselle Street
San Diego, California 92121
Country
United States of America
Secondary sponsor category [1] 301782 0
Other Collaborative groups
Name [1] 301782 0
MMC Medical International Services
Address [1] 301782 0
430 Forest Avenue
Laguna Beach, California 92651
Country [1] 301782 0
United States of America

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302676 0
Health and Disability Ethics Committees
Ethics committee address [1] 302676 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302676 0
New Zealand
Date submitted for ethics approval [1] 302676 0
12/03/2019
Approval date [1] 302676 0
Ethics approval number [1] 302676 0

Summary
Brief summary
Participants in this study will have an abnormal heart rhythm called paroxysmal atrial fibrillation. They will be
scheduled for an ablation to try to control this rhythm. All participants will have this scheduled as part of their clinical
management as discussed with their cardiologist.
To perform this procedure the cardiologist needs to put a small catheter into the left upper chamber of the heart. The
catheter is inserted into a vein in the leg and threaded into the top right chamber of the heart. From there a small
puncture (transseptal puncture) is made through the wall that separates the atria (top chambers) to allow access to
the left side. The AccessPath™ Transseptal Introducer Sheath System is designed to improve the precision and
safety of transseptal access in preparation for the ablation procedure by helping the doctor to more accurately
position the needle to make the puncture in the correct position.
This trial assesses the design and function of the AccessPath™ Transseptal Introducer Sheath System, which
consists of an introducer, guidewire and dilator with suction flute.
Fluoroscopy (x-rays) will be used to visually confirm positioning of the AccessPath™ Transseptal Introducer Sheath
throughout the procedure. It is usual for x-rays to be used for this procedure.
The doctor will use the AccessPath™ Transseptal Introducer Sheath System in accordance with the Instructions
for Use (IFU) and follow his/her standard practice for performing an ablation procedure for atrial fibrillation. It is
expected that the AccessPath™ Transseptal Introducer Sheath System will be used as part of the procedure, with
no changes required. The doctor will then perform the necessary ablation procedure. The participant will stay in
hospital overnight and have the standard tests performed, ECG and echocardiogram (ultrasound of the heart)to rule
out any complications before being discharged.
Study participation will end on discharge from hospital.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91030 0
Dr Ian Crozier
Address 91030 0
Cardiology Department Christchurch Hospital
PO Box 4710
Christchurch 8011
Country 91030 0
New Zealand
Phone 91030 0
+6433640640
Fax 91030 0
+6433786378
Email 91030 0
[email protected]
Contact person for public queries
Name 91031 0
Mrs Catherine Cruickshank
Address 91031 0
Cardiology Department Christchurch Hospital
2nd Floor Parkside West
Christchurch Hospital
Riccarton Avenue Christchurch 8011
Country 91031 0
New Zealand
Phone 91031 0
+6433641096
Fax 91031 0
Email 91031 0
[email protected]
Contact person for scientific queries
Name 91032 0
Ms Laura Minarsch
Address 91032 0
MMC Medical International Services
430 Forest Avenue
Laguna Beach, California 92651
Country 91032 0
United States of America
Phone 91032 0
+19492805700
Fax 91032 0
Email 91032 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
no data to share trial not planning to initiate


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.