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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Catheter ablation | Other |
| |
| Antiarrhythmic drugs | No Intervention | Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation using cryothermia | Procedure | Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia. |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laurent Pison, MD | Contact | + 31 43 3877095 | l.pison@mumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Maastricht | 6229 HX | Netherlands |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |