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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.
This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter.
Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective Observational | Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICE Image guidance | Device | ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures |
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| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure | During procedure |
| Imaging Success | Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator | During procedure |
| Clinical Success | Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. | During procedure |
| Number of Participants With 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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Inclusion Criteria:
Exclusion Criteria:
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All subjects age 18 and older that are scheduled for and will undergo a planned cardiac interventional percutaneous procedure in which the guidance of ICE is indicated, eligible and willing to sign an informed consent without meeting any of the exclusion criteria set and meeting all the inclusion criteria set forth in the protocol will be included in the population for analyses.
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| Name | Affiliation | Role |
|---|---|---|
| Rashmi Ram, PhD | Philips Clinical and Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States | ||
| Northwestern University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prospective Observational | Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance ICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 24, 2021 | Mar 20, 2024 |
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| Chicago |
| Illinois |
| 60208 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Prospective Observational | Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance ICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical Success | Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure | Posted | Count of Participants | Participants | During procedure |
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| |||||||||||||||||||||||||||
| Primary | Imaging Success | Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator | Posted | Count of Participants | Participants | During procedure |
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| ||||||||||||||||||||||||||||
| Primary | Clinical Success | Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. | Posted | Count of Participants | Participants | During procedure |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Device-related Adverse Event Detection | Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier. | Posted | Count of Participants | Participants | Procedure through 48 hours or discharge, whichever is earlier |
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Each subject's adverse event data were collected up to discharge or within 48 hours post procedure
Adverse event reporting does not differ from clinicaltrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Prospective Observational | Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance ICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures | 0 | 155 | 0 | 155 | 0 | 155 |
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No publication or presentation concerning a single site experience may be permitted until the multi-center study has been published. Notwithstanding the foregoing or in the event such multicenter publication is not submitted within twelve (12) months of completion of the Study at all sites or if Sponsor confirms there will be no multicenter publication, Principal Investigator shall furnish Sponsor with a copy of any proposed publication or presentation at least forty-five (45) days
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rashmi Ram, Director of Clinical Development | Philips IGTD | 719-464-6326 | rashmi.ram@philips.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 2, 2022 | Mar 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D006349 | Heart Valve Diseases |
| D006344 | Heart Septal Defects, Atrial |
| D054092 | Foramen Ovale, Patent |
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006343 | Heart Septal Defects |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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