A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
Conditions: Persistent Atrial Fibrillation, Cardiac Arrhythmia
Sponsor: CathVision ApS

 
 
A Prospective, Single Center, Pilot Study Using the CathVision ECGenius® system to Collect 
Electrogram Data to Test an Ablation Impact Algorithm 
 
NCT05458648 
23rd July 2022    
 

 
PROTOCOL SYNOPSIS 
 
Title 
A Prospective, Single Center, Pilot Study Using the CathVision ECGenius® 
system to Collect Electrogram Data to Test an Ablation Impact Algorithm 
Investigational 
Device 
CathVision ECGenius® System 
Intended Use 
To acquire, amplify, digitize, and record atrial intracardiac electrophysiology 
signals during cardiac electrophysiology studies for the treatment of persistent 
atrial fibrillation and to use the recorded data to test the performance of an 
ablation impact algorithm. 
Objectives 
Collect electrophysiological data during atrial fibrillation (AF) ablation 
procedures to test an algorithm for AF responses. 
Study Design 
A prospective, single-center, pilot study using the CathVision ECGenius® system 
and the Ablation Impact Analyzer software in radiofrequency (RF)  ablation 
procedures. 
Subjects with persistent atrial fibrillation who are indicated to undergo an RF 
ablation to treat persistent AF may be enrolled in the Study. Intracardiac signals 
will be passively recorded using the investigational ECGenius® System in 
parallel with the commercial (FDA Approved) EP Workmate, Abbott Inc. EP 
recording system. The investigational device will not be used for direct clinical 
care decisions or therapy. 
The validation of the automated algorithm will be performed 
offline. 
Sample Size 
Up to 30 patients may be enrolled in this pilot study. 
Investigational 
Site 
NYU Heart Rhythm Centre, New York, USA 
Study 
Duration / 
Follow-up 
Period 
Study enrollment is planned for one to three months. 
Primary 
Objective 
The Primary endpoint of the study will be evaluated as the safety and technical 
success of CathVision ECGenius® System to collect and record intracardiac 
signals during EP procedures. With focus on: 
The assessment of the performance of an ablation impact algorithm for analyzing 
AF responses.  

 
Secondary 
Objective 
The secondary objectives are: 
• 
Assessment of the performance of an AF cycle length algorithm  
Safety 
Endpoint 
Evaluation of adverse events and/or device malfunctions reported with 
the use of the CathVision ECGenius® System during the procedure until 
discharge. 
Enrollment 
Criteria 
Inclusion Criteria 
Eligible patients will meet all of the following inclusion criteria: 
 
1. Patients scheduled for RF ablation indicated by the investigator for the 
treatment of persistent atrial fibrillation.  
2. Male or female ≥ 21 years of age. 
3. Able and willing to provide written informed consent prior to any 
clinical investigation related procedure. 
 
Exclusion Criteria 
Eligible patients will not meet any of the following exclusion criteria: 
 
 
1. Current participation in another investigational drug or device 
study that interferes with this study. 
2. Patients who, in the opinion of the investigator, are not candidates 
for this study. 
3. Presence of other anatomic or comorbid conditions, or other medical, social, or 
psychological conditions that, in the investigator's opinion, could limit the 
patient's ability to participate in the clinical investigation or to comply with 
follow-up requirements, or impact the scientific soundness of the clinical 
investigation results. 
4. Life expectancy less than 12 month, in the opinion of the 
Investigator. 
5. Patients who are considered part of any vulnerable population. 
6. Patient is a prisoner.