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

Prior treatment

• 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.
• 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.
• 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).

Other illness

• Patients with uncontrolled bleeding disorders.
• Patients with uncontrolled bleeding disorders.
  • 5\. Patients who are pregnant, as confirmed by a positive pregnancy test.
  • Magnetic resonance imaging exclusion criteria:

Other

• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Patients who are pregnant, as confirmed by a positive pregnancy test.
  • General Exclusion Criteria
• TAVR conducted via other than transfemoral access (subclavian, axillar, transapical, transaortic, carotid or transcaval).
• Body Mass Index (BMI) and/or total body weight precluding imaging in scanner.
• 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).
• Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
• Claustrophobia precluding MRI scanning.

• 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.