Atrial Fibrillation Clinical Trial
Official title:
Cardiac Mapping of Autonomic Atrial Innervation and Its Relation to MIBG Nuclear Imaging in Patients With Atrial Fibrillation
Patients with symptomatic atrial fibrillation (AF), a rapid beating of the upper heart chambers, can undergo catheter ablation to control or eliminate their rhythm disorder. The radiopharmceutical 123I-mIBG (Adreview™ GE Healthcare) has been introduced to visually identify cardiac innervation. This study will use non-invasive evaluation using MIBG imaging to study if we can predict baseline autonomic characteristics in patients with AF, as well as clinical outcome based on post ablation imaging
This is a single centre, interventional, Phase III trial using the radiopharmaceutical
123I-mIBG for imaging. In this pilot study, up to 7 eligible participants will undergo
pre-ablation and post ablation nuclear imaging.
The major objective of our study is to evaluate the relationship between non-invasive
imaging of cardiac innervation with invasive mapping of atrial innervation as determined by
High Frequency Stimulation (standard of care to physiologically document autonomic
function). This will be followed by the clinical ablation procedure, as discussed by the
cardiac electrophysiologist, consisting of pulmonary vein (PV) antral isolation, inclusive
of regions of autonomic innervation, and sites showing complex fractionated atrial
electrograms (CFAE) when clinically indicated.
The secondary objective is to determine the relationship between catheter ablation of AF and
non-invasive nuclear imaging of cardiac innervation.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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