NCT06962371

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

GUARDIAN Australian Feasibility Study: Safety and Feasibility

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Transverse Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, single-arm, multi-center, open study to assess the clinical performance and safety of the Point-Guard CEPD during a TAVR procedure.

Conditions

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

Interventions

Type	Name	Description
DEVICE	cerebral embolic protection	Use of Transverse Medical Inc. Point-Guard CEP device.

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2025-05-08
• Last updated: 2025-05-08

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated device study