Clinical Trial

Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)

Study acronym: GUARDIAN
Recruiting
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Record status
This record was last updated May 8, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06962371
Lead Sponsor Transverse Medical, Inc.
Collaborators: Medical Metrics Diagnostics, Inc, Monash Health, Transverse Medical Australia, Ascend Clinical
Conditions Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement
Enrollment 30 participants
Start Date 2025-04-07
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-05-08