Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Aortic Valve Replacement
Conditions
Keywords
CEP, Cerebral Embolic Protection, CEP Device, TAVR, TAVI, stroke
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 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
Use of Transverse Medical Inc. Point-Guard CEP device.
Sponsors
Medical Metrics Diagnostics, Inc
Monash Health
Transverse Medical Australia
Ascend Clinical
Transverse Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint | From beginning of TAVI procedure to end. | 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). |
| Primary Safety Endpoints | Beginning of TAVI procedure to 30 days post-procedure. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Observational Endpoints | 24 hours pre-procedure to 24 hours post-procedure | 1\. Reduction in Median Total New Lesion Volume in whole-brain as assessed by traditional 1.5T DW-MRI as soon as possible and within twenty-four (24) hours post-procedure. \[Time Frame: Day 0-1 days Post-Procedure\] \- Total new lesion volume is defined as the sum of all diffusion- positive new cerebral lesions in post-TAVR DW-MRI relative to the pre-TAVR DW-MRI scans. (in mm\^3) |
Countries
Australia
Contacts
Primary ContactErin Spiegel, PhD
Backup ContactBlair Holman
Outcome results
None listed