NCT06962371 Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
| NCT ID | NCT06962371 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Transverse Medical, Inc. |
| Condition | Transcatheter Aortic Valve Implantation (TAVI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-04-07 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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. 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.
Contact & Investigator
Robert Gooley, MD
PRINCIPAL INVESTIGATOR
Monash Health
Frequently Asked Questions
Who can join the NCT06962371 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Transcatheter Aortic Valve Implantation (TAVI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06962371 currently recruiting?
Yes, NCT06962371 is actively recruiting participants. Contact the research team at erin.spiegel@transversemedical.com for enrollment information.
Where is the NCT06962371 trial being conducted?
This trial is being conducted at Clayton, Australia.
Who is sponsoring the NCT06962371 clinical trial?
NCT06962371 is sponsored by Transverse Medical, Inc.. The principal investigator is Robert Gooley, MD at Monash Health. The trial plans to enroll 30 participants.