Trial Outcomes & Findings for Philips Intracardiac Echocardiography (ICE) Clinical Registry (NCT NCT04950192)
NCT ID: NCT04950192
Last Updated: 2025-01-06
Results Overview
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure
Recruitment status
COMPLETED
Target enrollment
155 participants
Primary outcome timeframe
During procedure
Results posted on
2025-01-06
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
155
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Philips Intracardiac Echocardiography (ICE) Clinical Registry
Baseline characteristics by cohort
| Measure |
Prospective Observational
n=155 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
103 Participants
n=99 Participants
|
|
Age, Continuous
|
68.1 years
STANDARD_DEVIATION 14.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
88 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
112 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
32 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
155 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During procedureInvestigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure
Outcome measures
| Measure |
Prospective Observational
n=155 Participants
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
|
|---|---|
|
Technical Success
|
153 Participants
|
PRIMARY outcome
Timeframe: During procedureAdequate image quality via Likert scale ( Acceptable or better) as determined by the investigator
Outcome measures
| Measure |
Prospective Observational
n=155 Participants
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
|
|---|---|
|
Imaging Success
|
147 Participants
|
PRIMARY outcome
Timeframe: During procedureInvestigator'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.
Outcome measures
| Measure |
Prospective Observational
n=155 Participants
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
|
|---|---|
|
Clinical Success
|
149 Participants
|
PRIMARY outcome
Timeframe: Procedure through 48 hours or discharge, whichever is earlierDetect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier.
Outcome measures
| Measure |
Prospective Observational
n=155 Participants
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
|
|---|---|
|
Number of Participants With Device-related Adverse Event Detection
|
0 Participants
|
Adverse Events
Prospective Observational
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Rashmi Ram, Director of Clinical Development
Philips IGTD
Phone: 719-464-6326
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER