Autonomic Innervation and MIBG Imaging (MIBG-AF)

University of Ottawa Heart Institute

Status and phase

Completed

Phase 3

Conditions

Atrial Fibrillation

Treatments

Other: Iodine-123 Meta-iodobenzylguanidine

Study type

Interventional

Funder types

Other

Identifiers

NCT02071680

20140815-01H

Details and patient eligibility

About

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

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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