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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transcatheter Aortic Valve Implantation (TAVI) Aortic Valve Stenosis Transcatheter Aortic Valve Replacement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Point-Guard

Group Type EXPERIMENTAL

cerebral embolic protection

Intervention Type DEVICE

Use of Transverse Medical Inc. Point-Guard CEP device.

Interventions

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cerebral embolic protection

Use of Transverse Medical Inc. Point-Guard CEP device.

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No