Stroke Clinical Trial
Official title:
The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry
Verified date | March 2024 |
Source | Philips Clinical & Medical Affairs Global |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.
Status | Active, not recruiting |
Enrollment | 155 |
Est. completion date | July 30, 2024 |
Est. primary completion date | July 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 18 years of age and willing to provide written, dated and signed, informed consent 2. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU) Exclusion Criteria: 1. Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible 2. If alternate access (as needed instead of femoral) is not viable 3. Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease. |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
United States | Texas Cardiac Arrhythmia Research Foundation | Austin | Texas |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Northwestern University | Chicago | Illinois |
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Philips Clinical & Medical Affairs Global |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical Success | Successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure | During procedure | |
Primary | Imaging Success | Adequate image quality as determined by the investigator. | During procedure | |
Primary | Clinical Success | Adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. | During procedure | |
Primary | Device-related adverse event detection | Detect device-related adverse events periprocedural through discharge or =48 hours post-procedure, whichever is earlier. | Procedure through 48 hours or discharge, whichever is earlier |
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