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

NCT06962371 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-08

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

cerebral embolic protection

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

Sponsors & Collaborators

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Monash Health

    collaborator OTHER

  • Transverse Medical Australia

    collaborator UNKNOWN

  • Ascend Clinical

    collaborator UNKNOWN

  • Transverse Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Gooley, MD · Monash Health

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-03-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962371 on ClinicalTrials.gov