Clinical trial NCT06962371: Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
Official title: GUARDIAN Australian Feasibility Study: Safety and Feasibility
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Transcatheter Aortic Valve Implantation (TAVI)
Aortic Valve Stenosis
Transcatheter Aortic Valve Replacement
Keywords: CEP
Cerebral Embolic Protection
CEP Device
TAVR
TAVI
stroke
Lead sponsor: Transverse Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medical Metrics Diagnostics, Inc
name: Monash Health
name: Transverse Medical Australia
name: Ascend Clinical
First posted: 2025-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: Inclusion Criteria:

1. The patient is ≥18 years of age;
2. The patient meets indications for Transcatheter Aortic Valve Replacement (TAVR);
3. The patient is willing to comply with protocol-specified follow-up evaluations;
4. 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.

Exclusion Criteria:

1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
2. Anatomy that precludes safe delivery and retrieval of the investigational device.
3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
5. Patients with uncontrolled bleeding disorders.
6. Patients who are pregnant, as confirmed by a positive pregnancy test.

General Exclusion Criteria

1. TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
2. Anatomy that precludes safe delivery and retrieval of the investigational device.
3. Current or planned treatment with any investigational drug or investigational device during the study enrollment or follow-up period.
4. Cardiovascular surgical or interventional procedure 10 days prior or planned during the TAVR procedure or during the 30-day study follow-up.
5. Patients with uncontrolled bleeding disorders.

5. Patients who are pregnant, as confirmed by a positive pregnancy test.

Magnetic resonance imaging exclusion criteria:

1. Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
2. 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).
3. 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).
4. Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
5. Claustrophobia precluding MRI scanning.

Primary outcomes:
measure: Primary Endpoint
timeFrame: From beginning of TAVI procedure to end.
measure: Primary Safety Endpoints
timeFrame: Beginning of TAVI procedure to 30 days post-procedure.
Secondary outcomes:
Other outcomes:
measure: Observational Endpoints
timeFrame: 24 hours pre-procedure to 24 hours post-procedure
Locations:
city: Clayton
country: Australia
facility: Victorian Heart Hospital
state: Victoria
Study officials:
affiliation: Monash Health
name: Robert Gooley, MD
role: PRINCIPAL_INVESTIGATOR
References: