The Royal Brompton Hospital
London, SW3 6NP, United Kingdom
NCT Number: NCT02267889
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.
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Notify Me19 year–80 year
All sexes
Interventional
Not applicable
London, SW3 6NP, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: D-SPECT dedicated cardiac nuclear camera
Time frame: At the time of the ablation procedure.
Time frame: 12 months post the index ablation procedure.
Time frame: Up to 12 months from the index ablation procedure
Time frame: 12 months from the index ablation procedure.
Time frame: 12 months from the index ablation procedure.
AF/flutter/tachycardia burden will be modelled as a continuous variable with the number of episodes recorded.
Time frame: 6 months and 12 months post the index ablation procedure
Left atrial transport function will be assessed by echo as a categorical variable with 3 categories; poor, moderately impaired and normal.
Spectrum Dynamics
Industry
A Pilot Study on the Role pf Ganglionated Plexus Ablation for Catheter Ablation of Atrial Fibrillation.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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