Transcatheter Aortic Valve Implantation (TAVI)GUARDIANNCT06962371
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
A study testing cerebral embolic protection in people with Transcatheter Aortic Valve Implantation (TAVI) and Aortic Valve Stenosis, run by Transverse Medical, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- What is being tested?
- cerebral embolic protection
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is ≥18 years of age;
- The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
- The patient is willing to comply with protocol-specified follow-up evaluations;
- 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.
Who cannot join
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Anatomy that precludes safe delivery and retrieval of the investigational device.
- Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- Patients with uncontrolled bleeding disorders.
- Patients who are pregnant, as confirmed by a positive pregnancy test.
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- General Exclusion Criteria
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Anatomy that precludes safe delivery and retrieval of the investigational device.
- Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- Patients with uncontrolled bleeding disorders.
- 5. Patients who are pregnant, as confirmed by a positive pregnancy test.
- Magnetic resonance imaging exclusion criteria:
- Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
- 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).
- 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).
- Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
- Claustrophobia precluding MRI scanning.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Victorian Heart Hospital
Clayton, Victoria, 3168
Robert Gooley, MD, +6137511 1500, robert.gooley@monashhealth.org
Robert Gooley, MD
About this study
Official title: GUARDIAN Australian Feasibility Study: Safety and Feasibility
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.
Read the detailed description
This is a prospective, single-arm, multi-center, open study to assess the clinical performance and safety of the Point-Guard CEPD during a TAVR procedure.
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Being tested
- cerebral embolic protection
- Keywords
- CEP, Cerebral Embolic Protection, CEP Device, TAVR, TAVI, stroke
- Medical subject headings
- Aortic Valve Stenosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral embolic protectionDevice
Use of Transverse Medical Inc. Point-Guard CEP device.
| Study group | Role | What they receive |
|---|---|---|
| Point-Guard | Experimental | Not described Receives: Device: cerebral embolic protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
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).
Measured: From beginning of TAVI procedure to end.
Primary Safety Endpoints
- Primary Safety Endpoint: TAVR procedure complications associated with the delivery, positioning, and removal of the test device.
- 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.
Measured: Beginning of TAVI procedure to 30 days post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start7 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Implantation (TAVI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Transverse Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc, Monash Health, Transverse Medical Australia, Ascend Clinical
- Responsible party
- Sponsor
- Investigators
- Robert Gooley, MD, Principal investigator, Monash Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962371
- Sponsor's protocol ID
- CA-0007
- Acronym
- GUARDIAN
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: IPD to be used for internal device design validation only.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GUARDIAN Australian Feasibility Study: Safety and Feasibility
- ClinicalTrials.gov ID
- NCT06962371
- Acronym / sponsor ID
- GUARDIAN / CA-0007
- Conditions
- Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
- Keywords
- CEP, Cerebral Embolic Protection, CEP Device, TAVR, TAVI, stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Transverse Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc, Monash Health, Transverse Medical Australia, Ascend Clinical
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, multi-center, open study to assess the clinical performance and safety of the Point-Guard CEPD during a TAVR procedure.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Point-Guard | Experimental | Device: cerebral embolic protection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient is ≥18 years of age;
- The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
- The patient is willing to comply with protocol-specified follow-up evaluations;
- 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.
Key exclusion criteria (19 listed)
- TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
- Anatomy that precludes safe delivery and retrieval of the investigational device.
- Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
- Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
- Patients with uncontrolled bleeding disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cerebral embolic protectionUse of Transverse Medical Inc. Point-Guard CEP device. | Device | Point-Guard |
Primary outcome
Primary Endpoint
Time frame: From beginning of TAVI procedure to end.
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).
Primary Safety Endpoints
Time frame: Beginning of TAVI procedure to 30 days post-procedure.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No. IPD to be used for internal device design validation only.
Related trials for Transcatheter Aortic Valve Implantation (TAVI)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Gooley, MD principal investigator
Monash Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cerebral embolic protection in people with Transcatheter Aortic Valve Implantation (TAVI) and Aortic Valve Stenosis, run by Transverse Medical, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Spiegel, PhD (+13033252945, erin.spiegel@transversemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint (time frame: From beginning of TAVI procedure to end.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.