Clinical trial NCT02071680: Autonomic Innervation and MIBG Imaging
Official title: Cardiac Mapping of Autonomic Atrial Innervation and Its Relation to MIBG Nuclear Imaging in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
atrial cardiac innervation
catheter ablation of atrial fibrillation
High Frequency Stimulation
ganglionated plexuses
123I-mIBG
nuclear imaging
Lead sponsor: Ottawa Heart Institute Research Corporation
Sponsor class: OTHER
First posted: 2014-02-26
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years.
* Symptoms including one or more of the following: palpitations, shortness of breath, dizziness, presyncope or syncope, chest pain, tiredness or lack of energy.
* Failure of beta-blockers or at least one antiarrhythmic agent other than Amiodarone to prevent AF. In those patients who are not eligible to antiarrhythmic agents other than Amiodarone, patients may choose to undergo catheter ablation rather than starting Amiodarone.
* Paroxysmal (self-terminating AF within 7 days) or persistent AF (requiring an intervention to terminate or lasting more than 7 days).

Exclusion Criteria:

* Intracardiac thrombus as determined by transesophageal echocardiography
* Class III or IV congestive heart failure
* Persistent AF duration of more than 3 years
* Myocardial infarction within the last 6 months
* Left atrial size of greater than 55 mm determined by 2D echocardiogram
* Inability to undergo a transesophageal echocardiogram or cardiac CT
* Inability to undergo D-SPECT™ imaging
* Inability to take Warfarin or the new oral anticoagulants
* Previously received 123I-mIBG or 131I-mIBG
* History or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated imaging agents
* Use of medications for non-cardiac medical conditions that are known to interfere with 123I-mIBG uptake and these medications cannot be safely withheld for at least 24 hours before study procedures
* Diagnosis of or signs or symptoms of a neurologic disease such as Parkinson's disease, multiple systems atrophy or Parkinsonian syndromes, or other diseases known to affect the sympathetic nervous system
* Pregnancy as determined by a pre-procedure pregnancy tests

Primary outcomes:
measure: Concordance
timeFrame: 2 years
Secondary outcomes:
measure: Observation of effects
timeFrame: 2 years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
Study officials:
affiliation: Ottawa Heart Institute Research Corporation
name: Robert Lemery, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lemery R, Birnie D, Tang AS, Green M, Gollob M. Feasibility study of endocardial mapping of ganglionated plexuses during catheter ablation of atrial fibrillation. Heart Rhythm. 2006 Apr;3(4):387-96. doi: 10.1016/j.hrthm.2006.01.009. Epub 2006 Feb 28.
citation: Jacobson AF, Senior R, Cerqueira MD, Wong ND, Thomas GS, Lopez VA, Agostini D, Weiland F, Chandna H, Narula J; ADMIRE-HF Investigators. Myocardial iodine-123 meta-iodobenzylguanidine imaging and cardiac events in heart failure. Results of the prospective ADMIRE-HF (AdreView Myocardial Imaging for Risk Evaluation in Heart Failure) study. J Am Coll Cardiol. 2010 May 18;55(20):2212-21. doi: 10.1016/j.jacc.2010.01.014. Epub 2010 Feb 25.