Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900831
Status:
UNKNOWN
Last Update Posted:
2022-02-10
First Post:
2021-05-20
Brief Title:
Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping
Sponsor:
Imperial College Healthcare NHS Trust
Organization:
Imperial College Healthcare NHS Trust
Study Overview
Official Title:
Validation of Beat-to-beat Wavefront Direction Using Omnipolar Mapping
Status:
UNKNOWN
Status Verified Date:
2022-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ATOM
Brief Summary:
To validate omnipolar mapping in a well-described circuit within the heart Atrial Flutter and compare it with the gold standard of Local Activation Time LAT mapping during routine clinically indicated procedures of Atrial Flutter ablation A conventional LAT map will be created during the procedure prior to treatment to guide the procedure A repeat map will be performed after ablation during the procedure The investigators will export the map files for off-line analysis with the omnipolar software
Detailed Description:
Electroanatomical mapping of the chambers of the heart has revolutionised the way physicians treat heart rhythm disorders However there still are technical limitations that prevent us from gathering information that could be used to understand and treat these abnormal circuits in more detail
The gold standard technique in creating electrical maps of the heart in stable circuits is the Local Activation Time LAT map This map is formed by using a stable electrical point one of the electrode catheters within the heart - plastic tubes with metallic sensors at the end as a zero point and then collecting electrical data from around the heart based on timings off of that point This data is then loaded on a licenced software that creates the map These maps are very useful in creating electrical maps of the heart in relatively stable electrical circuits and can give us information on how the electrical current travels through the heart tissue These are widely used in guiding ablation by helping us locate areas to ablate apply local radiofrequency and burn part of the circuit deactivating it
In more unstable circuits such as in Atrial Fibrillation chaotic electrical activity at the top left chamber of the heart there are a lot of limitations of this technology as the electrical current changes from heart beat to heart beat and there is no stable zero point In the circuit to anchor the map in time In these situations real-time map creation with local electrical currents would be ideal as it would help us see the direction the electrical wave front travels in real time Our current electrical catheters have certain limitations which mainly have to do with difficulty in local electrical discrimination and detection of the orientation of the electrical current in real time
The Advisor HD Grid catheter by Abbott UK can overcome this hurdle It has a special electrode configuration 4 by 4 that creates 9 distinct anatomical spaces within the catheter grid that can triangulate micro current direction in real time omnipolar mapping This will greatly enhance our ability to quickly detect electrical wave fronts in unstable circuits such as Atrial Fibrillation which will lead to better understanding of the arrhythmia and identify targets for treatment quickly and efficiently
The investigators aim to first validate the robustness of omnipolar mapping in a well-described stable circuit such as Atrial Flutter and compare it to the gold standard of LAT mapping This will then help pave the way for use of this technology in more complex circuits such as Atrial Fibrillation
The gold standard technique in creating electrical maps of the heart in stable circuits is the Local Activation Time LAT map This map is formed by using a stable electrical point one of the electrode catheters within the heart - plastic tubes with metallic sensors at the end as a zero point and then collecting electrical data from around the heart based on timings off of that point This data is then loaded on a licenced software that creates the map These maps are very useful in creating electrical maps of the heart in relatively stable electrical circuits and can give us information on how the electrical current travels through the heart tissue These are widely used in guiding ablation by helping us locate areas to ablate apply local radiofrequency and burn part of the circuit deactivating it
In more unstable circuits such as in Atrial Fibrillation chaotic electrical activity at the top left chamber of the heart there are a lot of limitations of this technology as the electrical current changes from heart beat to heart beat and there is no stable zero point In the circuit to anchor the map in time In these situations real-time map creation with local electrical currents would be ideal as it would help us see the direction the electrical wave front travels in real time Our current electrical catheters have certain limitations which mainly have to do with difficulty in local electrical discrimination and detection of the orientation of the electrical current in real time
The Advisor HD Grid catheter by Abbott UK can overcome this hurdle It has a special electrode configuration 4 by 4 that creates 9 distinct anatomical spaces within the catheter grid that can triangulate micro current direction in real time omnipolar mapping This will greatly enhance our ability to quickly detect electrical wave fronts in unstable circuits such as Atrial Fibrillation which will lead to better understanding of the arrhythmia and identify targets for treatment quickly and efficiently
The investigators aim to first validate the robustness of omnipolar mapping in a well-described stable circuit such as Atrial Flutter and compare it to the gold standard of LAT mapping This will then help pave the way for use of this technology in more complex circuits such as Atrial Fibrillation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None