Clinical trial NCT05458648: A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
Official title: A Prospective Single Center Pilot Study Using the ECGenius System to Collect Electrogram Data to Test an Ablation Impact Algorithm
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Persistent Atrial Fibrillation
Cardiac Arrhythmia
Lead sponsor: CathVision ApS
Sponsor class: INDUSTRY
Collaborators: name: Medicept Inc.
First posted: 2022-07-14
Enrollment: 39
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients already referred to undergo a cardiac ablation as treatment for persistent atrial fibrillation

Brief summary: 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 signal complexity visualization algorithm.

Detailed description: 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 CathVision ECGenius system allows physicians and users to record intracardiac electrograms during human electrophysiological studies including treatments for atrial fibrillation and atrial tachycardias. Improvements to the first-generation system are in development and include software features and algorithms for further analysis and description of signals to improve the clinical utility of the recorded signals. These new algorithms and software features require leveraging clinical use data as part of the development and iteration process.

This study will allow the evaluation of algorithms for advanced signal analysis in a low-risk clinical setting by recording raw electrocardiograms during standard of care cardiac mapping and ablation treatments for tachyarrhythmias, specifically atrial tachycardias and atrial fibrillation. The data will be recorded by a conventional market-approved EP recording system and on a parallel investigational CathVision ECGenius system for subsequent offline prototype analysis. Information from the investigational system and algorithms will not be available to the physician during the treatment and will have no diagnostic or therapeutic impact on the clinical case.

The validation of the automated algorithm will be performed offline.

Eligibility 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.

Primary outcomes:
measure: Physician feedback on algorithm performance
timeFrame: One day - day of procedure
Secondary outcomes:
measure: Measurement of AF Cycle Length
timeFrame: One day - day of procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone
name: Larry Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References: