Status:
RECRUITING
Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
Lead Sponsor:
Transverse Medical, Inc.
Collaborating Sponsors:
Medical Metrics Diagnostics, Inc
Monash Health
Conditions:
Transcatheter Aortic Valve Implantation (TAVI)
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 devi...
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
- 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.
Exclusion
- 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.
- General Exclusion Criteria
- 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.
- 5\. Patients who are pregnant, as confirmed by a positive pregnancy test.
- Magnetic resonance imaging exclusion criteria:
- 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).
- Existing or planned implantation of a pacemaker or defibrillator implantation within the first 3 days after TAVR.
- Claustrophobia precluding MRI scanning.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06962371
Start Date
April 7 2025
End Date
March 1 2026
Last Update
May 8 2025
Active Locations (1)
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1
Victorian Heart Hospital
Clayton, Victoria, Australia, 3168