Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation

Study Overview
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Brief Summary
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This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.

Detailed Description
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The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advance™) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCath™ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.

Official Title
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Norwegian Randomized Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation (NO PERS-AF)

Conditions
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Persistent Atrial Fibrillation

Intervention / Treatment
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* Procedure: Pulmonary vein isolation with cryoballoon catheter.
* Procedure: Pulmonary vein isolation with radiofrequency ablation.


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients plan to undergo pulmonary vein isolation as the first procedure for symptomatic persistent atrial fibrillation (>7 days) and longstanding persistent atrial fibrillation (> 12 months, but ≤ 3 years) who are refractory to at least one class I or class III antiarrhythmic drug and required at least one electrical or pharmacologic cardioversion. Subject is at least 18 and ≤ 75 years old. Subject is able and willing to give informed consent. Exclusion criteria: Subject has paroxysmal atrial fibrillation (< 7days) or persistent atrial fibrillation with duration > 3 years. Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation. Subject has presence of an intracavitary thrombus. Subject has uncontrolled heart failure. Subject has severe valvular disease. Subject has the left atrial diameter > 60 mm confirmed by echocardiography. Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants. Subject has known cryoglobulinaemia. Subject has severe renal dysfunction. Subject who is or may potentially be pregnant. Subject has unstable angina pectoris. Subject has history of previous myocardial infarction or percutaneous intervention during the last three months. Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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<br>Pulmonary vein isolation with cryoballoon catheter. | Procedure: Pulmonary vein isolation with cryoballoon catheter.<br>* Device: Arctic Front Advance™ cardiac cryoablation catheter system.<br>|
| Active Comparator: Radiofrequency<br>Pulmonary vein isolation with radiofrequency ablation catheter. | Procedure: Pulmonary vein isolation with radiofrequency ablation.<br>* Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The freedom of any atrial arrhythmias at 12 months. | The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration > 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure duration | Procedure duration documented | 12 months | 
| Fluoroscopy time | Fluoroscopy time documented | 12 months | 
| Ablation time | Ablation time documented | 12 months | 
| Quality of life - Short Form (SF-36) Heath Survey | Short Form (SF-36) Heath Survey filled in by patients. | 12 months. | 
| Quality of life affected by atrial fibrillation. | The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients. | 12 months. | 
| Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias. | Hospitalization after the procedre | 12 months. | 
| The burden of atrial fibrillation | Total duration of atrial fibrillation recorded by 7-day Holter. | 12 months. | 
| The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter. | Atrial tachycardia or atrial flutter recorded by all types of ECG | 12 months. | 
| Symptoms related to atrial fibrillation. | Symptoms related to atrial fibrillation documented | 12 months. | 
| Serious adverse events. | Serious adverse events documented | 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Catheter Ablation