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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persistent AF Arm | Patients undergoing cardiac ablation for the treatment of persistent atrial fibrillation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Ablation for the treatment of persistent Atrial Fibrillation | Procedure | Patients participating in the study will undergo a cardiac ablation for the treatment of persistent atrial fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One day - day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of AF Cycle Length | Data collected during the study will be used to test an AF cycle length algorithm | At the start of the procedure from the insertion of the CS catheter to the first ablation |
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Inclusion Criteria:
Eligible patients will meet all of the following inclusion criteria:
Exclusion Criteria:
Eligible patients will not meet any of the following exclusion criteria:
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Patients already referred to undergo a cardiac ablation as treatment for persistent atrial fibrillation
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| Name | Affiliation | Role |
|---|---|---|
| Larry Jacob, MD | NYU Langone | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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1 patient was a screen failure (wrong rhythm) after having signed the informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2022 | Sep 9, 2025 |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | One day - day of procedure |
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| Secondary | Measurement of AF Cycle Length | Data collected during the study will be used to test an AF cycle length algorithm | Baseline AFCL | Posted | Mean | Standard Deviation | ms | At the start of the procedure from the insertion of the CS catheter to the first ablation |
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The day of the procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 34 | 1 | 34 | 3 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment | Procedure related groin hemorrhage |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | Systematic Assessment | Procedure related low blood pressure |
| |
| Atrial Tachycardia | Cardiac disorders | Systematic Assessment | Atrial arrhythmia |
| |
| Pericardial Effusion | Cardiac disorders | Systematic Assessment | Procedure related pericardial effusion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | CathVision ApS | 0702097102 | kpf@cathvision.com |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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