Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
5 participants
INTERVENTIONAL
2015-03-31
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Iodine-123 Meta-iodobenzylguanidine
123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation
Iodine-123 Meta-iodobenzylguanidine
A single injection of the 123I-mIBG will be given. Imaging will be done twice following injection: at 0120 minutes and 3-5 hours. The timing is dependent on the specific participant and imaging characteristics.
The imaging is done for approximately 24 minutes at each time point.
Interventions
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Iodine-123 Meta-iodobenzylguanidine
A single injection of the 123I-mIBG will be given. Imaging will be done twice following injection: at 0120 minutes and 3-5 hours. The timing is dependent on the specific participant and imaging characteristics.
The imaging is done for approximately 24 minutes at each time point.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Ottawa Heart Institute Research Corporation
OTHER
Responsible Party
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Robert Lemery
Principal Investigator
Principal Investigators
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Robert Lemery, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Heart Institute Research Corporation
Locations
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University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Countries
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References
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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.
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.
Other Identifiers
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20140815-01H
Identifier Type: -
Identifier Source: org_study_id