Non-fluoroscopy Ablation of AF/AT

Study Overview
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Brief Summary
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Atrial fibrillation is the most common arrhythmia but can be treated by a catheter procedure where specialized wires (so-called catheters) are inserted in the left upper heart chamber. This requires crossing the wall between the right and left atrium with a long needle (a so-called transseptal puncture or TSP). This is typically done using x-ray guidance or echo to check if the needle is in the right position. The investigators developed a method to do the TSP without x-rays using a specialized needle that can be also shown as a little icon on the 3D electroanatomical mapping system (CARTO).3D mapping systems are routinely used to track the location of the catheters in cath labs worldwide, but the position of the needle was not tracked yet. The investigators seek to demonstrate that these procedures can be carried out safely, successfully and in a reproducible fashion without any radiation by taking advantage of faking the isolated tip of the needle as a catheter on the 3D mapping system. The results will be compared with historic procedures done by the same operator in the years 2012-2017.

Detailed Description
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The hypothesis is that patients who undergo one or more TSP(s) for atrial fibrillation or left atrial tachycardia can be studied without the use of fluoroscopy which should result in a low or ZERO overall radiation exposure for the entire ablation procedure. The investigators will assess the feasibility, safety and efficacy of this new approach. The patient will be admitted in hospital as for a standard procedure and discharged the next day. Before admission, the patient undergoes a CMR/CT scan (routine in our centre). To avoid total radiation CMR would be preferred, if possible. The technique of the TSP and the use of the RF needle is commonly used worldwide. The ability to visualize the needle tip on the 3D electroanatomical mapping system facilitates the procedure. The additional visualization by TOE helps to assure that the fossa ovalis has been correctly identified. After the TSP, the ablation procedure itself will be carried out as conventionally performed using the catheter visualization on the 3D mapping system. An ECG and an echocardiogram are performed before discharge (as standard care). At 3 months the patient comes for the first visit and has an ECG, a Holter and symptom questionnaire. At 6 months, the patient has second visit which includes an ECG, a symptom questionnaire, a Holter and an echocardiogram. If recurrences of any arrhythmia occur, the patient can be scheduled for a second ablation procedure without any restrictions.

Official Title
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ZERO Radiation Exposure for Catheter Ablation of Atrial Fibrillation or Left Atrial Tachycardia

Conditions
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AF - Atrial Fibrillation, Atrial Tachycardia

Intervention / Treatment
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* Procedure: AF ablation or left-sided AT ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any type of atrial fibrillation or left atrial tachycardia Able to give written informed consent Age >18 years old and ≤ 80 years Fulfill established clinical criteria for catheter ablation of atrial fibrillation (1) No evidence of significant structural heart disease or congenital heart disease Exclusion Criteria: Intolerance or unwillingness to oral anticoagulation with Warfarin Bleeding disorder Contraindication to CT scan Presence of intracardiac thrombus Vascular disorder preventing access to femoral veins Cardiac congenital abnormality Severe, life threatening non-cardiac disease Active malignant disease and recent (<5 years) malignant disease Presence of ASD or PFO closure device Unable or unwilling to comply with F/U requirements Renal impairment Pregnancy

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
Intervention Model: Single Group Assignment
Interventional Model Description: prospective single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ablation for AF or left-sided AT<br>The patient will be admitted in hospital as for a standard ablation procedure and discharged the next day. The procedure will be carried out without using fluoroscopy and relying on the visualization of the electroanatomical mapping system. | Procedure: AF ablation or left-sided AT ablation<br>* According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the zero AF procedure | Absence of acute adverse events due to the use of non-fluoroscopic AF ablation • Evidence of chronic adverse events due to the use of non-fluoroscopic catheter ablation during the 6 months F/U period | 6 months | 
| Feasibility and efficacy | Assessment on efficacy of non-fluoroscopic AF acutely and if recurrences in 6 months follow up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrences | Time to first recurrence of AF/flutter/tachycardia (>30 sec) Freedom of AF on previously failed antiarrhythmic medication; time-dependant variable AF/flutter/tachycardia (> 30 sec) burden at 6 months F/U; this will be modelled as a continuous variable (number of episodes recorded) | 6 months |