Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Patients With Persistent AF

Study Overview
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Brief Summary
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Although circumferential pulmonary vein isolation (PVI) has been considered as the cornerstone for atrial fibrillation ablation, there has been a substantial recurrence rate. The investigators designed a prospectively randomized study to evaluate whether additional atrial ganglionated plexi ablation guided by the SUMO technology improves the clinical outcome in patients with persistent AF.

Official Title
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Atrial Ganglionated Plexi Ablation Guided by the SUMO Technology With and Without Conventional Pulmonary Vein Isolation in Persistent Atrial Fibrillation Patients: Prospective Randomized Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Pulmonary vein isolation
* Device: GP ablation guided by SUMO technology
* Device: ILR implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, age ≥ 18 and ≤ 80 years. Persistent AF (ECG documentation). Indication for AF ablation. LVEF ≥ 50% Able to provide written informed consent Able to comply with the requirements of the study Exclusion Criteria: Reversible cause of atrial fibrillation 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 Inability to undergo D-SPECT and CT imaging

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI group<br>Conventional PVI by circumferential antral ablation according to standard procedures. | Device: Pulmonary vein isolation<br>* CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.<br>Device: ILR implantation<br>* Implantation the ECG loop recorder according to standard procedure<br>|
| Experimental: PVI+GP guided by SUMO technology group<br>Conventional PVI by circumferential antral ablation according to standard procedures and atrial ganglionated plexi ablation guided by the SUMO technology. | Device: GP ablation guided by SUMO technology<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 of SUMO hotspots (in sinus rhythm if AF converts) • Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.<br>Device: ILR implantation<br>* Implantation the ECG loop recorder according to standard procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients without AF/AFl/AT |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first recurrence of AF or atrial tachycardia (AF burden > 0,5%). |  | 12 month | 
| Amount of mIBG uptake on 6 and 12 month DSPECT imaging in comparison to baseline D-SPECT. |  | 12 month |