Atrial FibrillationNCT04950192
Philips Intracardiac Echocardiography (ICE) Clinical Registry
An observational study of Atrial Fibrillation and Stroke, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke, Valve Disease, Heart
- What is being tested?
- ICE Image guidance
- Type of treatment
- Medical device
- How many people
- 155 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Oct 2021to 30 Jul 2023
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado
Aurora, Colorado, 80045
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern University
Chicago, Illinois, 60208
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: The Philips (VeriSight) Intracardiac Echocardiography (ICE) 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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect, Patent Foramen Ovale, Mitral Valve Disease
- Being tested
- ICE Image guidance
- Keywords
- ICE, Image guided therapy, Structural Heart, Electrophysiology, Intracardiac echocardiography, Atrial Fibrillation, Stroke, Ablation, Valve Disease
- Medical subject headings
- Atrial Fibrillation, Stroke, Heart Valve Diseases, Heart Septal Defects, Atrial, Foramen Ovale, Patent, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICE Image guidanceDevice
Also called Philips VeriSight ICE Catheter
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures
| Study group | Role | What they receive |
|---|---|---|
| Prospective Observational | Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance Receives: Device: ICE Image guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Success
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure
Measured: During procedure
Imaging Success
Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator
Measured: 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.
Measured: 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.
Measured: Procedure through 48 hours or discharge, whichever is earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start25 Oct 2021
- Primary completion30 Dec 2022
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rashmi Ram, PhD, Study director, Philips Clinical and Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950192
- Sponsor's protocol ID
- 2019_10745
- Other IDs
- 2019
- Status last verified
- Nov 2026
- First submitted
- 25 Jun 2021
- Last updated
- 3 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Philips (VeriSight) Intracardiac Echocardiography (ICE) Registry
- ClinicalTrials.gov ID
- NCT04950192
- Acronym / sponsor ID
- 2019_10745
- Conditions
- Atrial Fibrillation, Stroke, Valve Disease, Heart, Atrial Septal Defect, Patent Foramen Ovale, Mitral Valve Disease
- Keywords
- ICE, Image guided therapy, Structural Heart, Electrophysiology, Intracardiac echocardiography, Atrial Fibrillation, Stroke, Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Observational | – | Device: ICE Image guidanceProspective observational subjects undergoing planned cardiac procedures utilizing image guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICE Image guidanceAlso: Philips VeriSight ICE CatheterICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures | Device | Prospective Observational |
Primary outcome
Technical Success
Time frame: During procedure
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure
Imaging Success
Time frame: During procedure
Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator
Clinical Success
Time frame: During procedure
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.
Number of Participants With Device-related Adverse Event Detection
Time frame: Procedure through 48 hours or discharge, whichever is earlier
Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rashmi Ram, PhD study director
Philips Clinical and Medical Affairs
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Philips Clinical & Medical Affairs Global at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical Success (time frame: During procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.