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Trial registered on ANZCTR


Registration number
ACTRN12619000179134
Ethics application status
Approved
Date submitted
30/01/2019
Date registered
7/02/2019
Date last updated
4/02/2020
Date data sharing statement initially provided
7/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective, non-randomized, multi-center, open-label clinical investigation to assess the safety and technical performance of the Emboliner embolic protection catheter.
Scientific title
A prospective, non-randomized, multi-center, open-label clinical investigation to assess the safety and technical performance of the Emboliner embolic protection catheter.
Secondary ID [1] 297291 0
Nil
Universal Trial Number (UTN)
U1111-1227-6656
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
transcatheter aortic valve replacement 311314 0
embolic protection 311315 0
Condition category
Condition code
Cardiovascular 309949 309949 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The EmbolinerTM embolic protection catheter, manufactured by Emboline, Inc., is a temporarily-implanted aortic embolic filter for use during interventional cardiology procedures, such as transcatheter aortic valve replacement (TAVR). The Emboliner system consists of a single-use, sterile, heparin-coated Nitinol filter attached to a catheter, a delivery/retrieval sheath and dilator, a peelaway inserter, and a braid loading tool. The Emboliner is introduced through a femoral access site using the included delivery sheath and dilator. In TAVR procedures, the contralateral access site is used. The filter of the Emboliner is deployed across the aortic arch to prevent embolic debris that are generated during the procedure from reaching the cerebral circulation, and other vulnerable areas of the body. The integrated 6-Fr compatible lumen of the Emboliner catheter allows guidewires and diagnostic catheters to be introduced through the Emboliner during the procedure. The expandable access port of the Emboliner allows passage of catheters and delivery systems through the filter during the procedure. The use of the Emboliner device is expected to add minimal time to the overall TAVR procedure (approximately 15-30 minutes). The Emboliner device is used by the interventionalist performing the TAVR Procedure. At the end of the interventional procedure, the Emboliner is retrieved by withdrawal into the delivery/retrieval sheath, which is then removed from the body.
Intervention code [1] 313497 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318866 0
Safety:
Incidence of 30-day MACCE or Stage 3 acute kidney injury assessed through clinical examination, self-reported symptoms, and medical record review.

Timepoint [1] 318866 0
Safety to 30 days post procedure.
Primary outcome [2] 318867 0
Performance:
Defined as the ability to successfully access the aortic arch, position across the aortic arch and retrieve the Emboliner as reported by the investigator.
Timepoint [2] 318867 0
Immediately post procedure.
Secondary outcome [1] 366287 0
Incidence of in-hospital investigational device-related serious adverse events such as:
Air embolism
Introduction of catheter particulate matter
Allergic reaction to the device or study materials
Infection
Acute thrombosis or inflammatory response
Ischemic stroke or TIA
Aortic dissection or perforation
Mural thrombus formation
Access site complications

To be assessed by the study investigator and hospital staff through standard patient care and clinical assessment post TAVR. In adddition, the subject's medical records will be reviewed by the study monitors to understand medical history and any changes that might indicate the occurrence of an SAE post treatment.


Timepoint [1] 366287 0
To hospital discharge.
Secondary outcome [2] 366288 0
Incidence of investigational device-related serious adverse events at 30 days:

Air embolism
Introduction of catheter particulate matter
Allergic reaction to the device or study materials
Infection
Acute thrombosis or inflammatory response
Ischemic stroke or TIA
Aortic dissection or perforation
Mural thrombus formation
Access site complications

To be assessed by the study investigator and hospital staff through standard patient care and clinical assessment post TAVR. In adddition, the subject's medical records will be reviewed by the study monitors to understand medical history and any changes that might indicate the occurrence of an SAE after hospital discharge through the 30 day study contact.

Timepoint [2] 366288 0
To 30 days post procedure.

Eligibility
Key inclusion criteria
1. The patient must be 18 years and older
2. The patient must be a candidate for TAVR according
3. The patient has been provided written informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with an ascending aortic diameter [that meets the requirements of product labeling]
2. Patients with the linear distance from the femoral access site to the aortic valve root [per product labeling]
3. Patients not undergoing TAVR via the trans-femoral route.
4. Patients that are contraindicated for anticoagulant and/or antiplatelet therapy or uncorrected bleeding disorder.
5. Pregnant or nursing subjects, or subjects who intend to become pregnant during the term of the study.
6. Patients with known diagnosis of acute myocardial infarction (AMI) within 30 days preceding the index procedure.
7. Patients with known other mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year.
8. Patients with severe allergy to study materials or required medication that cannot be adequately pre-medicated or adequately controlled.
9. Patients with a history of a stroke or transient ischemic attack (TIA) within the prior 6 months.
10. Patients with an active peptic ulcer or history of upper gastrointestinal (GI) bleeding within the prior 3 months.
11. Patients with renal failure.
12. Patients presenting with cardiogenic shock or severe hypotension.
13. Patients with severe peripheral arterial disease that precludes delivery sheath vascular access, or whose vascular anatomy is unable to accommodate the access sheath.
14. Patients who have a planned treatment with any other investigational device or procedure during the study period.
15. Patients planned to undergo any other cardiac surgical or interventional procedure within two (2) weeks prior to the TAVR procedure, or 30 days after the TAVR procedure.
16. Patients with aortic implant or other abnormality (e.g., asymmetrical or sharp aortic calcifications).
17. Emergency patients.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
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
The number and percentage of patients who experience any of the pre-defined 30-day MACCE (consisting of death, stroke and Stage 3 AKI) will be presented. The 30-day MACCE data will be compared against a historical control MACCE rate of 12% from representative TAVR trials as described in Emboline engineering memo EM-0426, Historical MACCE Rates.

The number and percentage of patients in whom the device achieved technical success will be presented. Performance data will be reported by patient.

Recruitment
Recruitment status
Recruiting
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] 21230 0
New Zealand
State/province [1] 21230 0
North Island, South Island
Country [2] 21231 0
Israel
State/province [2] 21231 0
Jerusalem District
Country [3] 21232 0
Netherlands
State/province [3] 21232 0
South Holland, Utrecht

Funding & Sponsors
Funding source category [1] 301804 0
Commercial sector/Industry
Name [1] 301804 0
Emboline, Inc.
Address [1] 301804 0
Emboline, Inc.
849C Almar Ave., #278
Santa Cruz, CA 95060 USA
Country [1] 301804 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Emboline, Inc.
Address
Emboline, Inc.
849C Almar Ave., #278
Santa Cruz, CA 95060 USA
Country
United States of America
Secondary sponsor category [1] 301545 0
None
Name [1] 301545 0
Address [1] 301545 0
Country [1] 301545 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302511 0
The Institutional Helsinki Committee (IEC/IRB)
Ethics committee address [1] 302511 0
Hadassah Medical Organization, Ein Karem, Jerusalem
Mailing address: POB 1200,
Jerusalem 91120
Israel
Ethics committee country [1] 302511 0
Israel
Date submitted for ethics approval [1] 302511 0
01/01/2018
Approval date [1] 302511 0
17/05/2018
Ethics approval number [1] 302511 0
0664-17-HMO

Summary
Brief summary
A known complication of TAVR and similar procedures is the dislodging of embolic particles. Those particles may include blood clot, valvular tissue, or foreign material such as calcium. Once these particles have entered the bloodstream, it is possible that they might travel to the brain and cause neurological problems or stroke; or they may travel to other parts of the body, such as the kidneys, and cause damage; or they may lead to death.

The device being investigated in this study, the Emboliner embolic protection catheter, is a temporarily-implanted aortic embolic filter for use during cardiology interventions. The filter of the Emboliner is intended to stop these dislodged particles (embolic particles) from entering the bloodstream and travelling to other parts of the body. It is made of a metal called nitinol and is coated with a medication (heparin) that helps to prevent blood clotting on the device. The Emboliner is positioned in the aorta and is expanded so that it fits snuggly against the wall of the aorta. It is designed to filter the blood and capture any embolic particles. The device is then able to be retrieved and removed from the body, along with any embolic particles that may have been collected.

The objective of study is to evaluate the safety and performance of the Embo-liner embolic protection catheter.
Trial website
Not applicable.
Trial related presentations / publications
Not applicable.
Public notes
Not applicable.

Contacts
Principal investigator
Name 90466 0
Prof Haim D. Danenberg, M.D.
Address 90466 0
Department of Cardiology, Hadassah Hebrew University Medical Center, POB 12000, Jerusalem, 9112001, Israel
Country 90466 0
Israel
Phone 90466 0
+972-2-6778654
Fax 90466 0
Email 90466 0
danen@hadassah.org.il
Contact person for public queries
Name 90467 0
Mr Scott Russell
Address 90467 0
Emboline, Inc.
849C Almar Ave., #278
Santa Cruz, CA 95060 USA
Country 90467 0
United States of America
Phone 90467 0
1 831 900 5020
Fax 90467 0
1 831 900 5019
Email 90467 0
clinical@emboline.com
Contact person for scientific queries
Name 90468 0
Mr Scott Russell
Address 90468 0
Emboline, Inc.
849C Almar Ave., #278
Santa Cruz, CA 95060 USA
Country 90468 0
United States of America
Phone 90468 0
1 831 900 5020
Fax 90468 0
1 831 900 5019
Email 90468 0
clinical@emboline.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Line by line patient data will not be publicly available. Summary data and resulting analyses will be publicly available should the study results be published.
What supporting documents are/will be available?
No other documents available
Summary results
No Results