Evaluation of the Point-Guard device during heart valve replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Victorian Heart Hospital
  Clayton, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Robert Gooley, MD — Monash Health
• Study coordinator: Erin Spiegel, PhD
• Email: erin.spiegel@transversemedical.com
• Phone: +13033252945

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SYMmetric Valve expansion to reduce hypoattenuated leaflet thickening after balloon-expandable TAVI

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.