Evaluation of the Point-Guard device during heart valve replacement

GUARDIAN Australian Feasibility Study: Safety and Feasibility

This study is testing a new device called Point-Guard to see if it can help prevent brain problems during heart valve replacement surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Transverse Medical, Inc. (Industry-sponsored)
• Locations: 1 site (Clayton, Victoria)
• Trial ID: NCT06962371 on ClinicalTrials.gov

What this trial studies

This study assesses the feasibility and safety of the Point-Guard cerebral embolic protection device during Transcatheter Aortic Valve Replacement (TAVR) procedures. It is a prospective, single-arm, multi-center, open study aimed at evaluating the device's clinical performance and functionality. Participants will undergo TAVR while using the Point-Guard device to determine its effectiveness in preventing cerebral embolic events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are indicated for TAVR and can comply with follow-up evaluations.

Not a fit: Patients who have anatomical issues preventing safe delivery of the device or those with uncontrolled bleeding disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety of TAVR procedures by reducing the risk of cerebral embolic events.

How similar studies have performed: Other studies have explored cerebral embolic protection during TAVR, but the specific use of the Point-Guard device is novel.

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.

Where this trial is running

Clayton, Victoria

• Victorian Heart Hospital — Clayton, Victoria, Australia (Recruiting)

Study contacts

• Principal investigator: Robert Gooley, MD — Monash Health
• Study coordinator: Erin Spiegel, PhD

Conditions Transcatheter Aortic Valve Implantation; Aortic Valve Stenosis; Transcatheter Aortic Valve Replacement; CEP; Cerebral Embolic Protection; CEP Device; TAVR; TAVI