CACAF2 Study: Catheter Ablation for Cure of Atrial Fibrillation

Study Overview
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Brief Summary
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The objective of this prospective multicenter randomized study is to establish the effectiveness of treatment of persistent atrial fibrillation by encircling the pulmonary veins with radiofrequency (RF) ablation and creating additional lines of block with the aid of the NAVISTAR® THERMOCOOL® catheter in conjunction with the CARTO™ EP Navigation System. Effectiveness will be determined by comparing the chronic success of ablation therapy versus antiarrhythmic drug therapy, defined as the absence of persistent tachyarrhythmias during the first 24 months after a run-in phase of 2 months.

Official Title
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Catheter Ablation for Cure of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: RF ablation
* Drug: Antiarrhythmic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years Written informed consent One documented relapse of atrial fibrillation (AF) during antiarrhythmic drug therapy after an electrical cardioversion Exclusion Criteria: Permanent atrial fibrillation Patients who had tried >1 antiarrhythmic drug (Class I or Class III). AF was the sole rhythm for >6 months before the enrollment. Previous ablation for AF. AF is deemed secondary to a transient or correctable abnormality including electrolyte imbalance, trauma, recent surgery, infection, toxic ingestion, and endocrinopathy. Patients who have fibrillation episodes triggered by another uniform arrhythmia (eg, atrial flutter or atrial tachycardia). Patients with intra-atrial thrombus, tumor, or another abnormality that precludes catheter introduction. Patients with Wolf-Parkinson-White syndrome. Patients awaiting cardiac transplantation. Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-III-IV or ejection fraction (EF) <40%. Patients with unstable angina or acute myocardial infarction within 3 months. Patients with cardiac revascularization or other cardiac surgery within 6 months. Patients with heart disease in which corrective surgery is anticipated. Patients in whom appropriate vascular access is precluded. Pregnant women. A separate requirement for antiarrhythmic drug treatment, which will require an antiarrhythmic drug not previously tried for AF suppression. Prior atrial surgery. Contraindication to treatment with warfarin or other bleeding diathesis. Renal failure requiring dialysis. Hepatic failure. Participant in investigational clinical or device trial. Unwilling or unable to give informed consent. Inaccessible for follow-up. Psychological problem that might limit compliance. Active abuse of alcohol or other drugs which may be causative of AF. An implanted device (pacemaker or cardioverter-defibrillator). Left atrial diameter (anteroposterior) >50 mm.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Experimental: 1<br>Catheter ablation | Device: RF ablation<br>* Catheter ablation with NAVISTAR® THERMOCOOL® Catheter in conjunction with CARTO™ EP Navigation System<br>|
| Active Comparator: 2<br>Antiarrhythmic drugs | Drug: Antiarrhythmic drugs<br>* Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Absence of Persistent Atrial Tachyarrhythmias Relapse During the First 24 Months After the run-in Phase (2 Months). | Persistent atrial tachyarrhythmia is defined as lasting 7 or more days per two consecutive transtelephonic monitoring or electrocardiogram recordings (obtained at least one week apart) with no cardioversions. | within first 24 months after a 2-month run-in phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Total Absence of Any Documented Atrial Tachyarrhythmias Lasting Longer Than 30 Seconds During the First 24 Months After the run-in Phase (2 Months) |  | within first 24 months after a 2-month run-in phase | 
| Percentage of Procedural Success | Procedural success was determined on the day of the procedure (Day 0) and was based on responses to the following: Has a validation of the lesions been performed by taking 3 points inside each circular lesion? If YES to #1, did you observe that none of them exceed 0.1 mV? Did you observe any adverse event during the procedure? If the answers to (1 ) and (2 ) were YES and (3) was NO, then the procedure was determined a success. | The day of the procedure | 
| Time to First Recurrence of Any Tachyarrhythmias Lasting 30 or More Seconds After the Run in Phase |  | day 61 through 790 | 
| Percentage of Participants Achieving Clinical Success (Subjects Taking AADs That Remain Free From Any Tachyarrhythmias) in Association With Antiarrhythmic Drugs |  | at 26 months and at each patients last follow-up visit | 
| Quality of Life |  | at 14, 26 and 38 months | 
| Health-economics Parameters (Days of Hospitalization) |  | at 26 months and at each patients last follow-up visit | 
| Percentage of Participants With Normal Sinus Rhythm at the Last Follow-up Visit Measured by ECG and 24-hour Holter Monitor |  | at each patients last follow-up visit |