N/A
N=155
Philips Intracardiac Echocardiography (ICE) Clinical Registry
Atrial Fibrillation · Stroke · Valve Disease, Heart · Atrial Septal Defect · Patent Foramen Ovale
Bottom Line
View on ClinicalTrials.gov: NCT04950192 ↗Enrolled (actual)
155
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Technical Success — 153 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ICE Image guidance (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Philips Clinical & Medical Affairs Global
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Technical Success |
153 | — |
| PRIMARY Imaging Success |
147 | — |
| PRIMARY Clinical Success |
149 | — |
| PRIMARY Number of Participants With Device-related Adverse Event Detection |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 18 years of age and willing to provide written, dated and signed, informed consent
- Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)
Exclusion Criteria
- Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
- If alternate access (as needed instead of femoral) is not viable
- 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.
Data sourced from ClinicalTrials.gov (NCT04950192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.