Trial Outcomes & Findings for Feasibility Study on the VERAFEYE System (NCT NCT05931835)
NCT ID: NCT05931835
Last Updated: 2026-02-10
Results Overview
The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
During the procedure (up to two hours)
Results posted on
2026-02-10
Participant Flow
Of 18 enrolled participants, 17 underwent catheter ablation procedure with VERAFEYE System.
1 of 18 enrolled subjects was classified as an intent subject (no VERAFEYE Imaging Catheter inserted into the body).
Participant milestones
| Measure |
Catheter-ablation Arm
Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation.
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study on the VERAFEYE System
Baseline characteristics by cohort
| Measure |
Catheter-ablation Arm
n=17 Participants
Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation.
|
|---|---|
|
Age, Continuous
|
66.2 years
STANDARD_DEVIATION 7.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Ireland
|
17 participants
n=4 Participants
|
|
Height
|
176.9 cm
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Weight
|
91.2 kg
STANDARD_DEVIATION 15.7 • n=4 Participants
|
|
Resting Heart Rate
|
75.8 bpm
STANDARD_DEVIATION 18.7 • n=4 Participants
|
|
Systolic BP
|
135.4 mmHg
STANDARD_DEVIATION 21.1 • n=4 Participants
|
|
Diastolic BP
|
85.6 mmHg
STANDARD_DEVIATION 13.8 • n=4 Participants
|
|
12-lead ECG at Baseline
Atrial Fibrillation
|
7 Participants
n=4 Participants
|
|
12-lead ECG at Baseline
Sinus Rhythm
|
7 Participants
n=4 Participants
|
|
12-lead ECG at Baseline
Atrial Flutter
|
2 Participants
n=4 Participants
|
|
12-lead ECG at Baseline
Atrial Fibrillation AND Atrial Flutter
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: During the procedure (up to two hours)The objective of the study is to collect physician feedback by means of a questionnaire on the VERAFEYE System. Results from this study may be used to guide development and refinement of the VERAFEYE System.
Outcome measures
| Measure |
Catheter-ablation Arm
n=17 Participants
Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter or atrial fibrillation.
|
|---|---|
|
Physician Feedback on VERAFEYE System
How feasible was it for you to integrate the usage of the System into your workflow? rated as easy
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Were the views and the possibilities for manipulating the views helpful? slightly helpful and above
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Visualization of the LA from the RA rated acceptable and above
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
VERAFEYE Imaging Catheter (VIC) rated as able to navigate to RA
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Introduction of the VIC into the vasculature&navigation to the RA rated as acceptable and above
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Visualization of major anatomical structures (excl. LA) from the RA rated as acceptable and above
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Articulation/maneuverability of the VIC rated acceptable and above
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Ability of the System to visualize the third party devices rated acceptable and above
|
100 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Overall image quality 2D rated acceptable and above
|
94.1 percentage of participants
|
|
Physician Feedback on VERAFEYE System
Overall image quality 4D rated acceptable and above
|
88.2 percentage of participants
|
|
Physician Feedback on VERAFEYE System
No anatomical locations were difficult to reach with the VIC
|
100 percentage of participants
|
Adverse Events
Catheter-ablation Arm
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
Elke Sommerijns, Director of Clinical and Medical Affairs
LUMA Vision
Phone: +32
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place