RecruitingNot ApplicableNCT06962371

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

GUARDIAN Australian Feasibility Study: Safety and Feasibility

Sponsor

Transverse Medical, Inc.

Enrollment

30 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Transcatheter Aortic Valve Implantation (TAVI)

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called cerebral embolic protection for people with aortic valve stenosis, transcatheter aortic valve implantation (tavi), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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