Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.

Official Title
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Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Catheter ablation using cryothermia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years Never taken antiarrhythmic drugs or at most a pill in the pocket approach Willingness, ability and commitment to participate in baseline and follow-up evaluations Exclusion Criteria: Paroxysmal AF for more than three years An episode of atrial fibrillation that lasted more than seven days within the past six months Persistent/permanent atrial fibrillation Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis) Documented atrial flutter Structural heart disease of clinical significance including: Cardiac surgery within six months of screening Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction <30% as measured by echocardiography or catheterization Unstable angina Myocardial infarction within six months of screening Surgically corrected atrial septal defect with a patch or closure device LA size > 40mm Any prior ablation of the pulmonary veins Enrollment in any other ongoing protocol Untreatable allergy to contrast media Pregnancy Any contraindication to cardiac catheterization Prosthetic mitral heart valve Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.) Contraindication to coumadin or heparin History of pulmonary embolus or stroke within one year of screening Acute pulmonary edema Atrial clot on TEE regardless of the patient's anticoagulation medication status

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Catheter ablation<br> | Procedure: Catheter ablation using cryothermia<br>* Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.<br>|
| No Intervention: Antiarrhythmic drugs<br>Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up |  | 3 years | 
| comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires |  | 3, 6, 12, 24 and 36 months | 
| number of track complications, both acute (during the procedure) and chronic throughout the trial |  | 3 years | 
| hospitalization rate during a two and a half year follow-up following the initial six months follow-up |  | 3 years |