Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)
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.
Study details:
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
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
- 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
DEVICE_FEASIBILITY
Phase
- NA
Study ID
NCT06962371
Intervention or treatment
DEVICE: cerebral embolic protection
Conditions
- Transcatheter Aortic Valve Implantation (TAVI)
- Aortic Valve Stenosis
- Transcatheter Aortic Valve Replacement
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Research sites nearby
Closest Location:
Victorian Heart Hospital
Select from list below to view details:
Victorian Heart Hospital
Clayton, Victoria, Australia
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Who is running the clinical trial?
Transverse Medical, Inc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Point-Guard
| Device: cerebral embolic protection |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Technical success, defined as successful deployment, positioning and retrieval per the Instructions For Use (IFU), with minimal device interference, and as outlined below: * Deployment of the Point-Guard filter unit from the Delivery sheath into the aortic arch; * Positioning of the Point-Guard device within the aortic arch; * Retrieving and removing the Point-Guard device intact; * Minimal device interference (operator assessed). | From beginning of TAVI procedure to end. |
| Primary Safety Endpoints | 1. Primary Safety Endpoint: TAVR procedure complications associated with the delivery, positioning, and removal of the test device. 2. Primary Safety Endpoint: MACCE (all death, all stroke, and acute kidney injury class 3) within 72 hours or discharge, whatever occurs first and at 30 days. | Beginning of TAVI procedure to 30 days post-procedure. |
Secondary Outcome
References
Clinical Trials Gov: Clinical Feasibility and Evaluation Study of POINT-GUARD Embolic Protection Device During TAVR (GUARDIAN)Other trials to consider
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