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The purpose of this study is to compare radiofrequency catheter ablation and antiarrhythmic drug treatment for the maintenance of sinus rhythm in paroxysmal atrial fibrillation patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Treatment | Active Comparator |
| |
| ThermoCool Radiofrequency Catheter | Active Comparator | Radiofrequency catheter used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation, antiarrhythmic drugs | Device | Patients receive either treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of Atrial Fibrillation | To compare the incidence of recurrence of Atrial Fibrillation in the two groups over a follow-up period of one year. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ablation and drug treatment | Evaluation of:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Jais, MD | Hôpital Haut Lèvêque | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19029470 | Derived | Jais P, Cauchemez B, Macle L, Daoud E, Khairy P, Subbiah R, Hocini M, Extramiana F, Sacher F, Bordachar P, Klein G, Weerasooriya R, Clementy J, Haissaguerre M. Catheter ablation versus antiarrhythmic drugs for atrial fibrillation: the A4 study. Circulation. 2008 Dec 9;118(24):2498-505. doi: 10.1161/CIRCULATIONAHA.108.772582. Epub 2008 Nov 24. |
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| Amiodarone, flecainide, propafenone, quinidine, dofetilide, sotalol, cibenzoline, beta blocking and calcium channel blocking agents and antiarrhythmic drugs | Drug | Amiodarone will be taken at 600 mg per day for 21 days (as a loading dose) followed by 1.4g per week or 200mg per day. The daily dose may be increased to 300mg or 2.1g per week. |
|
| ThermoCool Radiofrequency Catheter | Device | Patient is ablated once, repeat ablation if paroxysmal atrial fibrillation reoccurs. |
|
| One year |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Mid-Ohio Cardiology | Columbus | Ohio | 43214 | United States |
| Hôpital Haut Lèvêque | Pessac | Paris | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| Hopital Cantonal de Geneve | Geneva | 12111 | Switzerland |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000638 | Amiodarone |
| D005424 | Flecainide |
| D011405 | Propafenone |
| D011802 | Quinidine |
| C063533 | dofetilide |
| D013015 | Sotalol |
| C032151 | cifenline |
| D002121 | Calcium Channel Blockers |
| D000889 | Anti-Arrhythmia Agents |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000077264 | Calcium-Regulating Hormones and Agents |
| D045505 | Physiological Effects of Drugs |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
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