Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04900831 |
| Other study ID # |
19HH5064 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 18, 2020 |
| Est. completion date |
August 1, 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Imperial College Healthcare NHS Trust |
| Contact |
Dimitrios Panagopoulos |
| Phone |
+447858778189 |
| Email |
d.panagopoulos[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
