GUARDIAN Australian Feasibility Study: Safety and Feasibility
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Australia
Victorian Heart Hospital
RECRUITING
Clayton
Contact Information
Primary
Erin Spiegel, PhD
erin.spiegel@transversemedical.com
+13033252945
Backup
Blair Holman
blair.holman@transversemedical.com
+13033252945
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2026-03
Participants
Target number of participants: 30
Treatments
Experimental: Point-Guard
Related Therapeutic Areas
Sponsors
Collaborators: Monash Health, Ascend Clinical, Transverse Medical Australia, Medical Metrics Diagnostics, Inc
Leads: Transverse Medical, Inc.