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RECRUITING
NCT06962371
NA

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

Sponsor: Transverse Medical, Inc.

View on ClinicalTrials.gov

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.

Official title: GUARDIAN Australian Feasibility Study: Safety and Feasibility

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-04-07

Completion Date

2026-03

Last Updated

2025-05-08

Healthy Volunteers

No

Interventions

DEVICE

cerebral embolic protection

Use of Transverse Medical Inc. Point-Guard CEP device.

Locations (1)

Victorian Heart Hospital

Clayton, Victoria, Australia