Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a sub study of the Pure EP 2.0 trial. In a redo atrial fibrillation population, this study is designed to collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure. These signals are later evaluated for clinical relevance and impact on the procedure.
Cardiac electrophysiologists rely on the display of electrograms when performing EP studies and catheter ablations in patients with arrhythmias. To achieve effective outcomes without complications, it is vital that the recording system enables the recognition of clearly abnormal (scared myocardium) and normal electrical signals.
In a redo Atrial Fibrillation (AF) procedure, the patient had previously undergone an AF ablation procedure, but is still having AF episodes, which can be life threatening and have been shown to lead to strokes. Since the original AF procedure involved burning or freezing of myocardial tissue, this is now additional scar tissue and may cause more complex electrograms and intracardiac signals.
In this sub study, both the PURE EPâ„¢ system and the GE Cardiolab system will be running and recording signals during the entire procedure, with one of the systems displayed on the screen in the procedure room to guide the physician's decision-making. Even numbered subjects will be PURE EPâ„¢ guided and odd numbered subjected will be GE CardioLab guided. All other aspects of the procedure will proceed per standard of care. The study will be collect pulmonary vein signals pre and post ablation therapy, along with other non-pulmonary vein signals of interest during a redo ablation procedure.
After the physician has completed ablation treatment, matching signals of interest will be extracted from both the PURE EPâ„¢ system and the GE Cardiolab recording system as described in the main study. At a later date, a blinded electrophysiologist reviewer will evaluate the signals from both systems with a focus on tissue viability signals and the impact on the procedure. The survey results will then be compared to see the differences in clinical procedure decision-making based on the signal samples.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PURE EP Guided Procedures | Redo AF procedures guided by Pure EP System during an AF Ablation |
| |
| Standard Recording System Guided Procedures | Redo AF procedures guided by the Standard Recording System during an AF Ablation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pure-EP | Device | Advanced Signal Acquisition and Processing |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the clinical procedure impact of PURE-EP signals of interest vs. a standard recording system in a Redo AF population | The signals of interest will undergo a homogenization process to remove all identifiers of the system used. At a later time, a blinded electrophysiologist reviewer will evaluate the signals for clinical relevance and procedural impact from both systems using the same Blinded Signal Assessment Form. The Blinded Assessment Form results will be compared to both each other and what was done at the procedure. | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Atrial Fibrillation
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. David's Medical Center | Austin | Texas | 78758 | United States |
Collected intracardiac signal samples will be shared with the independent electrophysiologist reviewers, other physician investigators, and possibly other study collaborators like a biostatistician and clinical research organization
The stored intracardiac signal samples from each enrolled subject will become available for review post-procedure and indefinitely.
Access to the stored intracardiac electrogram signals will be determined and managed by BioSig Technologies.
Not provided
Not provided
Not provided
Not provided
Not provided