Comparison of the Ganglionated Plexi Activity in Patients With Different Forms of Atrial Fibrillation Guided by SUMO Technology

Study Overview
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Brief Summary
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The purpose of this study is to compare DUA (discrete uptake accumulations) of mIBG activity in patients with different forms of atrial fibrillation and within a sub-group of healthy subjects.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Cardiac CT
* Procedure: Ablation Procedure
* Device: D-SPECT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, age ≥ 18 and ≤ 80 years. Male or female, age ≥ 50 years in the healthy volunteers group No heart pathology (for volunteers) PAF, Pers AF and L-s Pers AF (ECG documented). LVEF ≥ 50% Able to provide written informed consent Able to comply with the requirements of the study Exclusion Criteria: Previous AF ablation therapy Clinical evidence of active coronary ischemia, significant valvular heart disease, or hemodynamically significant congenital cardiac abnormality Recent (3 months) myocardial infarction (MI), stroke or transient ischemic attack (except if the patient had a DES implanted stent post-MI it would be one year) Contra-indication to Iodine-123 Meta-iodobenzylguanidine (123I-mIBG), iodine, isoproterenol Use of medication for non-cardiac medical conditions that is known to interfere with 123I-mIBG uptake and cannot be safely withheld for at least 24 hours prior to the D-SPECT study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volunteers<br>Healthy volunteers | Device: Cardiac CT<br>* Cardiac CT - contract enhanced cardiac CT according to standard protocol D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden) Merge CT and D-SPECT image data to generate SUMO map.<br>Device: D-SPECT<br> <br> |
| Active Comparator: PAF<br>Patients with paroxysmal atrial fibrillation | Device: Cardiac CT<br>* Cardiac CT - contract enhanced cardiac CT according to standard protocol D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden) Merge CT and D-SPECT image data to generate SUMO map.<br>Procedure: Ablation Procedure<br>* CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts) Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA Control HFS At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures. Exit and entrance block confirmation Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.<br>Device: D-SPECT<br> <br> |
| Active Comparator: Pers AF<br>Patients with persistent atrial fibrillation | Device: Cardiac CT<br>* Cardiac CT - contract enhanced cardiac CT according to standard protocol D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden) Merge CT and D-SPECT image data to generate SUMO map.<br>Procedure: Ablation Procedure<br>* CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts) Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA Control HFS At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures. Exit and entrance block confirmation Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.<br>Device: D-SPECT<br> <br> |
| Active Comparator: L-s Pers AF<br>Patients with long-standing persistent atrial fibrillation | Device: Cardiac CT<br>* Cardiac CT - contract enhanced cardiac CT according to standard protocol D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden) Merge CT and D-SPECT image data to generate SUMO map.<br>Procedure: Ablation Procedure<br>* CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts) Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA Control HFS At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures. Exit and entrance block confirmation Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia.<br>Device: D-SPECT<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| location of discrete uptake accumulations |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events |  | 1 week |