Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04964440 |
Other study ID # |
Redo AF Sub Study of Pure EP 2 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
March 3, 2021 |
Est. completion date |
January 29, 2022 |
Study information
Verified date |
February 2022 |
Source |
BioSig Technologies, Inc. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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 EP™ 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 EP™ 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 EP™ 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.