Actively Recruiting
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
Led by Transverse Medical, Inc. · Updated on 2025-05-08
30
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
T
Transverse Medical, Inc.
Lead Sponsor
M
Medical Metrics Diagnostics, Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 years of age or older
- Patient meets indications for Transcatheter Aortic Valve Replacement (TAVR)
- Patient is willing to comply with protocol-specified follow-up evaluations
- Patient has been informed about the study, agrees to its provisions, and has provided written informed consent approved by an Institutional Review Board or Ethics Committee
You will not qualify if you...
- TAVR conducted via access other than transfemoral (such as subclavian, axillar, transapical, transaortic, carotid, or transcaval)
- Anatomy that prevents safe delivery and retrieval of the investigational device
- Current or planned treatment with any investigational drug or device during study enrollment or follow-up
- Cardiovascular surgical or interventional procedure within 10 days before or planned during TAVR or 30-day follow-up
- Patients with uncontrolled bleeding disorders
- Patients who are pregnant, as confirmed by a positive pregnancy test
- Body mass index or weight too high for MRI scanning
- Contraindications to MRI, including implantable pacemakers, defibrillators, metal implants or fragments in brain or eye
- High risk of complete AV block requiring permanent pacemaker after TAVR
- Planned or existing pacemaker or defibrillator implantation within 3 days after TAVR
- Claustrophobia preventing MRI scanning
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Victorian Heart Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
Research Team
E
Erin Spiegel, PhD
CONTACT
B
Blair Holman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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