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Trial registered on ANZCTR


Registration number
ACTRN12622000473763
Ethics application status
Approved
Date submitted
3/03/2022
Date registered
25/03/2022
Date last updated
15/08/2022
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and Technical Performance Evaluation of the Emboliner Embolic Protection Device: A New Zealand Experience
Scientific title
Safety and Technical Performance Evaluation of the Emboliner Embolic Protection Device: A New Zealand Experience
Secondary ID [1] 306590 0
Nil known
Universal Trial Number (UTN)
U1111-1275-3151
Trial acronym
SafePass 3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transcatheter aortic valve replacement 325483 0
Embolic protection 325484 0
Condition category
Condition code
Cardiovascular 322869 322869 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Emboliner system consists of a single-use, sterile, heparin-coated Nitinol filter attached to a catheter and its associated delivery system. The Emboliner is introduced through a femoral access site using the provided custom delivery sheath. In TAVR procedures, the contralateral access site is used. The filter of the Emboliner is deployed across the aortic arch to prevent embolic debris 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. 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.

The Emboliner addresses the limitations of the current technologies with the following unique features:

• Circumferential coverage: intended to cover all cerebral branch vessels with less positional sensitivity than embolic deflecting panels

• Closed downstream end: captures and removes both cerebral and non-cerebral embolic debris

• Integrated lumen: allows device deployment via the typical angiographic pigtail access site used in a TAVR procedure with no additional procedural access required

• Expandable access port: allows easy passage of procedural devices (e.g., TAVR delivery systems) through the Emboliner filter while maintaining complete embolic protection

• Catheter-based device: provides ease-of-use and active control of the filter throughout the procedure (consistent with typical cardiology procedural tools) for adaptability (ease of learning curve)

Operation and treatment with the device, to include device deployment, device insertion, deployment duration, and device removal, will be performed by trained device operators, to include the study principal investigator, and all sub-investigator’s delegated device operation responsibilities.

Prior to the index procedure, patients requiring transcatheter aortic valve replacement will be evaluated for study participation. If they appear to meet inclusion criteria, and consent to screening, they will be evaluated for study eligibility.

Following the TAVR procedure, the Emboliner system will be removed immediately after the operation.

Use of the Emboliner device is expected to add approximately 15-20 minutes to the overall TAVR procedure. Actual timing of procedure will be followed and documented.

All study cases will undergo review for compliance through the study monitoring process.

Intervention code [1] 323016 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330651 0
Incidence of 30-day MACCE, as defined as the composite of all death, all stroke, or stage 3 acute kidney injury (at discharge or 72 hours post index procedure.
MACCE is an acronym for Major Adverse Cardiovascular and Cerebrovascular Event.

These data will be collected through a review of medical records, audit of study records, patient follow-up, and protocol required evaluations.
Timepoint [1] 330651 0
Safety to 30 days post procedure.
Primary outcome [2] 330652 0
Technical performance (technical success) will be defined as the ability to successfully access the aortic arch with successful Emboliner positioning followed by retrieval from the study subject.

These criteria will be assessed by the operating physician as well as the angiographic core laboratory using imaging provided for analysis.
Timepoint [2] 330652 0
Performance endpoint immediately post procedure.
Secondary outcome [1] 407092 0
Incidence of investigational device related serious adverse events to 30 days.

Examples of such adverse events are as follows:
- Access site complication such as swelling (edema)
- Pain/sore/tender at access site
- Ischemic stroke or transient ischemic attack (TIA)
- Thrombus formation
- Embolism

All adverse events regardless of relationship to the study device will be reported. AEs will be identified through patient follow up care, clinical examination, review of medical records and/or any other mechanism by which an adverse event is noted.
Timepoint [1] 407092 0
Follow up will be at 30 days post procedure. This outcome will be assessed at the 30-day post treatment timepoint.

Eligibility
Key inclusion criteria
The subject must present with symptomatic severe aortic stenosis and be eligible for treatment with either an Edwards Sapien or Medtronic Evolut valve and corresponding TAVR procedure according to current guidelines and have consented to the TAVR procedure.

The subject and the treating physician agree that the subject will return for required post-procedure follow-up visit.

The subject or the subject's legal representative has been informed of the nature of the trial, has agreed to its provisions, and has provided written informed consent as approved by the IRB/EC of the respective clinical site.

The subject must be 18 years or older at the time of consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject is not undergoing TAVR via the trans-femoral route.

Subject has severe allergy or contraindication to aspirin, heparin, bivalirudin, clopidogrel, and/or contrast sensitivity that cannot be adequately controlled.

Subject has uncorrected bleeding disorder.

Subject has hypercoagulable states that cannot be corrected.

Subject has known diagnosis of acute myocardial infarction (AMI) within the established study period.

Subject has a history of substance abuse that may cause non-compliance with the protocol or confound the data interpretation.

Subject presents with cardiogenic shock, hemodynamic instability requiring inotropic support or mechanical heart assistance, or severe hypotension at the time of screening.

Subject has a history of a stroke or transient ischemic attack (TIA) within the established study period.

Subject's valve/valve disease is not indicated for use with the Emboliner System.

Subject has blood dyscrasias.

Subject has hypertrophic cardiomyopathy with or without obstruction.

Subject has severe ventricular dysfunction.

Subject has echocardiographic evidence of intracardiac or aortic mass, thrombus, or vegetation.

Subject has an active infection.

Subject has neurodegenerative or other progressive neurological disease or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

Subject has undergone carotid stenting or carotid endarterectomy within the previous 6 months; or subject has symptomatic or asymptomatic severe occlusive carotid disease requiring concomitant CEA/stenting.

Subject presents with renal failure at the time of screening.

Subject has a planned treatment with any other investigational device or procedure during the study period.

Subject has undergone balloon valvuloplasty (BAV) within the established period prior to treatment.

Subject is planning to undergo any other cardiac surgical or interventional procedure.

Subject has a need for emergency surgery.

Subject is pregnant or nursing, or subject intends to become pregnant during the term of the study.

Subject is unable or unwilling to complete all required screening and/or follow-up assessments, including subjects with active major psychiatric disease; with severe visual, auditory, or learning impairment; or who are unable to comprehend English.

The investigator considers participation in the study to not be in the subject’s best interest.

Subject presents with anatomical limitations precluding the use of the investigational device.

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
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a small-scale safety and technical performance study. All statistical analysis for this study will be descriptive in nature. The 30-day MACCE rate as assessed on a per-patient basis will be compared against a historical control MACCE rate of 12% from representative TAVR trials as described in Emboline engineering memo EM-0426. This analysis is for informational purposes and is not statistically empowered based on the small sample size.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/04/2022
Actual
7/07/2022
Date of last participant enrolment
Anticipated
15/09/2022
Actual
Date of last data collection
Anticipated
31/10/2022
Actual
Sample size
Target
20
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 24637 0
New Zealand
State/province [1] 24637 0
Auckland
Country [2] 24638 0
New Zealand
State/province [2] 24638 0
Waikato

Funding & Sponsors
Funding source category [1] 310921 0
Commercial sector/Industry
Name [1] 310921 0
Emboline, Inc.
Country [1] 310921 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Emboline, Inc.
Address
2901 Mission Street, Bldg 2
Santa Cruz, CA 95060 USA
Country
United States of America
Secondary sponsor category [1] 312216 0
None
Name [1] 312216 0
Address [1] 312216 0
Country [1] 312216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310481 0
Northern B Health and Disabilities Ethics Committees
Ethics committee address [1] 310481 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 310481 0
New Zealand
Date submitted for ethics approval [1] 310481 0
09/03/2022
Approval date [1] 310481 0
03/06/2022
Ethics approval number [1] 310481 0

Summary
Brief summary
Cerebral embolism is a known complication of cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, and electrophysiology procedures, Embolic particles, which may include thrombus, valvular tissue, and foreign material, may become dislodged by surgical or catheter manipulations and enter the bloodstream. Cerebral embolism can lead to neurological and neurocognitive deficits, stroke, or death. The accumulation of subclinical lesions is associated with increased risk of dementia and reduced resistance to future brain insult. Other organs downstream can also be damaged by embolism, resulting in diminished function or organ failure. These risks are especially critical in percutaneous heart valve therapies (PHVT), such as transcatheter aortic valve replacement (TAVR). New white matter brain lesions have been noted using MRI in about 70-95% of TAVR patients following the procedure, indicating high risks of long-term ischemic damage. Furthermore, when TAVR is performed with a cerebral embolic protection device, debris is captured in up to 99% of the patients with captured particles as large as 2 mm in size. The use of embolic protection devices has been shown to significantly reduce the volume of new ischemic lesions in TAVR patients. Further, their use significantly reduces the incidence of peri-procedural strokes during TAVR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117818 0
Dr Sanjeevan Pasupati, MD
Address 117818 0
Waikato Hospital
10 Pembroke Street Hamilton 3204
New Zealand
Country 117818 0
New Zealand
Phone 117818 0
+64 7 8397136
Fax 117818 0
+64 7 8397140
Email 117818 0
[email protected]
Contact person for public queries
Name 117819 0
Scott Russell
Address 117819 0
Emboline, Inc.
2901 Mission Street, Bldg 2
Santa Cruz, CA 95060
Country 117819 0
United States of America
Phone 117819 0
+1 831 900 5020
Fax 117819 0
+1 831 900 5019
Email 117819 0
[email protected]
Contact person for scientific queries
Name 117820 0
Scott Russell
Address 117820 0
Emboline, Inc.
2901 Mission Street, Bldg 2
Santa Cruz, CA 95060
Country 117820 0
United States of America
Phone 117820 0
+1 831 900 5020
Fax 117820 0
+1 831 900 5019
Email 117820 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
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 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.