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This study evaluates the effect of catheter ablation of ganglionated plexi (GP) for the treatment of adult patients with atrial fibrillation heart arrhythmias. The location of GP will be demonstrated by a novel nuclear imaging cardiac camera. 3D images from the cardiac camera will guide the GP ablation procedure.
Catheter ablation procedures are nowadays routine procedures in patients with drug-refractory atrial fibrillation (AF). However, ablation success for patients even in the early stages of AF is currently only around 70% and may require multiple procedures.
The intrinsic cardiac autonomic nervous system (ANS), which forms a neural network, has been shown to be a critical element responsible for the initiation and maintenance of AF. Autonomic inputs to the heart converge at several locations; these convergence points are typically embedded in the epicardial fat pads and form ganglionated plexi (GP) that contain autonomic ganglia and nerves. In human hearts, there are at least 7 GP and the 4 major left atrial GP are located around the antrum of the pulmonary veins (PVs). High-frequency stimulation (HFS; 20 Hz, 10-150 V and pulse width 1-10 ms) can localize GP during an invasive electrophysiology (EP) study.
A novel dedicated cardiac nuclear imaging camera with solid-state detectors (D-SPECT, Spectrum Dynamics) has demonstrated significantly improved sensitivity and image resolution and can provide novel imaging information on previously 'invisible' structures like the GP. Using this 3D image information to guide GP ablation could significantly facilitate AF ablation and result in improved ablation outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Image guided GP ablation | Experimental | Use of cardiac nuclear imaging data to guide GP ablation procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image guided GP ablation | Procedure | 3D imaging data from the D-SPECT system will be used to visualise the GP and guide the location of catheter ablation sites during the electrophysiology procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Termination of atrial fibrillation during image guided ablation | At the time of the ablation procedure. | |
| Freedom from atrial fibrillation/flutter/tachycardia (>30 seconds) off antiarrhythmic medication at the end of 12 months following the index ablation procedure. | 12 months post the index ablation procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first recurrence of atrial fibrillation/flutter/tachycardia (>30 seconds) | Up to 12 months from the index ablation procedure | |
| Freedom from atrial fibrillation on previously failed antiarrhythmic medication | 12 months from the index ablation procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Ernst, MD | The Royal Brompton Hospital, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Brompton Hospital | London | SW3 6NP | United Kingdom |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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|
| D-SPECT dedicated cardiac nuclear camera | Device |
|
| Atrial fibrillation/flutter/tachycardia (>30 seconds) burden at 12 months post the index ablation procedure. | AF/flutter/tachycardia burden will be modelled as a continuous variable with the number of episodes recorded. | 12 months from the index ablation procedure. |
| Left atrial transport function | Left atrial transport function will be assessed by echo as a categorical variable with 3 categories; poor, moderately impaired and normal. | 6 months and 12 months post the index ablation procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |