Autonomic Innervation and MIBG Imaging (MIBG-AF)
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|ClinicalTrials.gov Identifier: NCT02071680|
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Other: Iodine-123 Meta-iodobenzylguanidine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cardiac Mapping of Autonomic Atrial Innervation and Its Relation to MIBG Nuclear Imaging in Patients With Atrial Fibrillation|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation
Other: 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 Name: 123I-mIBG
- Concordance [ Time Frame: 2 years ]The concordance of the 123I-mIBG visual images with the identification of autonomic sites as determined by high frequency stimulation (HFS).
- Observation of effects [ Time Frame: 2 years ]The effects of radiofrequency ablation of AF on cardiac innervation will be observed visually on 123l-mlBG images and clinically with participant follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02071680
|University of Ottawa Heart Institute|
|Ottawa, Ontario, Canada, K1Y 4W7|
|Principal Investigator:||Robert Lemery, MD||Ottawa Heart Institute Research Corporation|