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

NCT06962371 | Recruiting FDA Device

• 1 other identifier: CA-0007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CEP; Cerebral Embolic Protection; CEP Device; TAVR; TAVI; stroke

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint

  Technical success, defined as successful deployment, positioning and retrieval per the Instructions For Use (IFU), with minimal device interference, and as outlined below: * Deployment of the Point-Guard filter unit from the Delivery sheath into the aortic arch; * Positioning of the Point-Guard device within the aortic arch; * Retrieving and removing the Point-Guard device intact; * Minimal device interference (operator assessed).

  From beginning of TAVI procedure to end.

• Primary Safety Endpoints

  1. Primary Safety Endpoint: TAVR procedure complications associated with the delivery, positioning, and removal of the test device. 2. Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3) within 72 hours or discharge, whatever occurs first and at 30 days.

  Beginning of TAVI procedure to 30 days post-procedure.

Other Outcomes (1)

• Observational Endpoints

  24 hours pre-procedure to 24 hours post-procedure

Study Arms (1)

Point-Guard

EXPERIMENTAL

Device: cerebral embolic protection

Interventions

cerebral embolic protection DEVICE

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

Point-Guard

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is ≥18 years of age;
• The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
• The patient is willing to comply with protocol-specified follow-up evaluations;
• The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board or Ethics Committee.

You may not qualify if:

• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Anatomy that precludes safe delivery and retrieval of the investigational device.
• Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
• Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• Patients with uncontrolled bleeding disorders.
• Patients who are pregnant, as confirmed by a positive pregnancy test.
• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Anatomy that precludes safe delivery and retrieval of the investigational device.
• Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
• Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
• Patients with uncontrolled bleeding disorders.
• \. Patients who are pregnant, as confirmed by a positive pregnancy test.
• Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
• Contraindications to MRI (subjects with any implantable temporary or permanent pacemaker or defibrillator, metal implants in field of view, metallic fragments, clips, or devices in the brain or eye before TAVR procedure).
• High risk of complete AV block after TAVR, with the need of permanent pacemaker (e.g., subjects with pre-existing bifascicular block or complete right bundle branch block plus any degree of AV block).

Sponsors & Collaborators

• Transverse Medical, Inc.: lead
• Medical Metrics Diagnostics, Inc: collaborator
• Monash Health: collaborator
• Transverse Medical Australia: collaborator
• Ascend Clinical: collaborator

Study Sites (1)

Victorian Heart Hospital

Clayton, Victoria, 3168, Australia

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis; Stroke

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Robert Gooley, MD

  Monash Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Spiegel, PhD

CONTACT

+13033252945; erin.spiegel@transversemedical.com

Blair Holman

CONTACT

+13033252945; blair.holman@transversemedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: May 8, 2025
• Study Start: April 7, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)