Autonomic Innervation and MIBG Imaging

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Other: Iodine-123 Meta-iodobenzylguanidine

• Registration Number: NCT02071680
• Lead Sponsor: Ottawa Heart Institute Research Corporation

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.

Study Timeline

• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-02-21
• Study First Posted: 2014-02-26
• Study Start: 2015-03
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Iodine-123 Meta-iodobenzylguanidine	Iodine-123 Meta-iodobenzylguanidine	123I-mIBG administration followed by nuclear imaging pre-ablation and post-ablation

Primary Outcome Measures

Name	Time	Method
Concordance	2 years	The concordance of the 123I-mIBG visual images with the identification of autonomic sites as determined by high frequency stimulation (HFS).

Secondary Outcome Measures

Name	Time	Method
Observation of effects	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.

Trial Locations

Locations (1)

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Ontario, Canada