Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation. The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.

Official Title
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Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Radiofrequency Ablation
* Procedure: Cryoballoon ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication. Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure Age range of 18 - 85 years Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead. Patients must be able and willing to provide written informed consent to participate in the clinical trial. Exclusion Criteria: Congenital heart disease, age younger than 18 years, significant valve disease, LA size >55 mm, and severe heart failure (ejection fraction < 30% and/or New York Heart Association class IV). Presence of a mechanical prosthetic valve. Secondary causes of atrial fibrillation Documented intra-atrial thrombus or another abnormality which precludes catheter introduction. Social factors that would preclude follow up or make compliance difficult.- Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cryoballoon ablation<br>Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. | Procedure: Cryoballoon ablation<br>* Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.<br>* Other names: Pulmonary vein isolation;|
| Active Comparator: Radiofrequency Ablation<br>Contact force-sensing radiofrequency left atrial ablation with 3D mapping system. | Procedure: Radiofrequency Ablation<br>* Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.<br>* Other names: Pulmonary vein isolation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from atrial tachycardia/fibrillation | Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of AF episodes recorded. |  | 12 months | 
| Duration of AF episodes recorded. |  | 12 months | 
| Length of postoperative hospital stay. |  | 1 month | 
| Total procedural time. |  | 1 day | 
| Fluoroscopy time |  | 1 day | 
| Left atrial instrumentation time | total time during which there are catheters in the LA | 1 day | 
| Hospitalizations after discharge. | number of hospitalizations after discharge | 12 months | 
| Procedure-related complications | Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal. | 1 week | 
| Incidence of cerebrovascular events from the time of the operation up to 90 days. |  | 90 Days | 
| Long-term success | freedom from AF/AFL/AT recurrences following the 3-month blanking period within 36-month follow-up from the date of the ablation procedure in the absence of Class I and III antiarrhythmic drug therapy. | 36 months | 
| Freedom from clinical or stroke-relevant AF/AFL/AT. | Freedom from AF/AFL/AT with duration cutoff > 1 hour | 12 months | 
| Freedom from persistent AF/AFL/AT (duration cutoff of 7 days) | Freedom from AF/AFL/AT with duration cutoff > 7 days | 12 months | 
| Regression from persistent to non-paroxysmal atrial fibrillation | Patients converted into paroxysmal forms of AF. | 12 months | 
| Significant reduction in AF burden | >75% reduction from pre- to postablation and/or total postablation burden <12% | 12 months | 
| Low daily AF burden | Patients with AF burden less than 1%- 2% | 12 months | 
| Death from any cause |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Persistent atrial fibrillation, Catheter ablation