Cardiac Arrhythmia, Persistent Atrial Fibrillation
Conditions
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.
Interventions
Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation.
Sponsors
CathVision ApS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ability to Collect CS Data | One day - day of procedure | Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of AF Cycle Length | At the start of the procedure from the insertion of the CS catheter to the first ablation | Data collected during the study will be used to test an AF cycle length algorithm |
Countries
United States
Participant flow
Pre-assignment details
1 patient was a screen failure (wrong rhythm) after having signed the informed consent.
Participants by arm
| Arm | Count |
|---|---|
| Persistent AF Arm Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation
Cardiac Ablation for the treatment of persistent Atrial Fibrillation: Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation. | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Patient presented in atrial flutter | 1 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Persistent AF Arm |
|---|---|
| Age, Continuous | 67.7 years STANDARD_DEVIATION 11.03 |
| Height | 175.28 cm STANDARD_DEVIATION 11.64 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 28 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 3 / 34 |
| serious Total, serious adverse events | 1 / 34 |
Outcome results
Primary
Ability to Collect CS Data
Data collected during the study will be used to test a signal complexity visualization algorithm. The primary outcome measure was the ability of the system to achieve this in each patient.
Time frame: One day - day of procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Persistent AF Arm | Ability to Collect CS Data | 34 Participants |
Secondary
Measurement of AF Cycle Length
Data collected during the study will be used to test an AF cycle length algorithm
Time frame: At the start of the procedure from the insertion of the CS catheter to the first ablation
Population: Baseline AFCL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Persistent AF Arm | Measurement of AF Cycle Length | 169.64 ms | Standard Deviation 24.27 |