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Recruiting NCT06962371

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

No phase Interventional Transcatheter Aortic Valve Implantation (TAVI) Aortic Valve Stenosis Transcatheter Aortic Valve Replacement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: cerebral embolic protection.
Who it may be relevant to
Registry conditions: Transcatheter Aortic Valve Implantation (TAVI), Aortic Valve Stenosis, Transcatheter Aortic Valve Replacement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GUARDIAN Australian Feasibility Study: Safety and Feasibility

Overview

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.

Interventions

  • Device cerebral embolic protection
    Use of Transverse Medical Inc. Point-Guard CEP device.

Primary outcome measures

  • Primary Endpoint [Time frame: From beginning of TAVI procedure to end.]
  • Primary Safety Endpoints [Time frame: Beginning of TAVI procedure to 30 days post-procedure.]

Eligibility criteria

Inclusion criteria

  • 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 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.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Australia · 1 center
  • Victorian Heart Hospital — Clayton

Identifiers

NCT: NCT06962371 · CA-0007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗