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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06962371
Registration number
NCT06962371
Ethics application status
Date submitted
3/04/2025
Date registered
8/05/2025
Date last updated
8/05/2025
Titles & IDs
Public title
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
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Scientific title
GUARDIAN Australian Feasibility Study: Safety and Feasibility
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Secondary ID [1]
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CA-0007
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Universal Trial Number (UTN)
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Trial acronym
GUARDIAN
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Transcatheter Aortic Valve Implantation (TAVI)
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Aortic Valve Stenosis
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Transcatheter Aortic Valve Replacement
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - cerebral embolic protection
Experimental: Point-Guard -
Treatment: Devices: cerebral embolic protection
Use of Transverse Medical Inc. Point-Guard CEP device.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Primary Endpoint
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Assessment method [1]
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Technical success, defined as successful deployment, positioning and retrieval per the Instructions For Use (IFU), with minimal device interference, and as outlined below: * Deployment of the Point-Guard filter unit from the Delivery sheath into the aortic arch; * Positioning of the Point-Guard device within the aortic arch; * Retrieving and removing the Point-Guard device intact; * Minimal device interference (operator assessed).
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Timepoint [1]
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From beginning of TAVI procedure to end.
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Primary outcome [2]
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Primary Safety Endpoints
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Assessment method [2]
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1. Primary Safety Endpoint: TAVR procedure complications associated with the delivery, positioning, and removal of the test device. 2. Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3) within 72 hours or discharge, whatever occurs first and at 30 days.
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Timepoint [2]
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Beginning of TAVI procedure to 30 days post-procedure.
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Eligibility
Key inclusion criteria
1. The patient is =18 years of age;
2. The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
3. The patient is willing to comply with protocol-specified follow-up evaluations;
4. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
2. Anatomy that precludes safe delivery and retrieval of the investigational device.
3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
5. Patients with uncontrolled bleeding disorders.
6. Patients who are pregnant, as confirmed by a positive pregnancy test.
General Exclusion Criteria
1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
2. Anatomy that precludes safe delivery and retrieval of the investigational device.
3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
5. Patients with uncontrolled bleeding disorders.
5. Patients who are pregnant, as confirmed by a positive pregnancy test.
Magnetic resonance imaging exclusion criteria:
1. Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
2. Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
3. High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).
4. Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
5. Claustrophobia precluding MRI scanning.
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/04/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2026
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Victorian Heart Hospital - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Transverse Medical, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Medical Metrics Diagnostics, Inc
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Monash Health
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Transverse Medical Australia
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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Ascend Clinical
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Address [4]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to assess the feasibility and safety of the Transverse Medical, Inc. Point-Guard device. This feasibility study is a limited clinical investigation of the Point-Guard device. The study will be conducted to evaluate the device design concept with respect to clinical safety and device functionality.
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Trial website
https://clinicaltrials.gov/study/NCT06962371
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert Gooley, MD
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Address
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Monash Health
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Erin Spiegel, PhD
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Address
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Country
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Phone
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+13033252945
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Fax
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Email
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erin.spiegel@transversemedical.com
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06962371
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