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The aim of this randomized study is to evaluate the efficacy of two different approaches for conversion of persistent atrial fibrillation, the non-invasive one (external electrical cardioversion) and the invasive one (catheter ablation).
This randomized study compares two treatment strategies in patients with persistent atrial fibrillation: Cardioversion vs. catheter ablation. Cardioversion is a low risk standard treatment option for patients with persistent atrial fibrillation. However, mid- and long term efficacy (regarding the maintenance of sinus rhythm) is low. Catheter ablation is an invasive treatment which has been reported to result in up to 60-70% of patients in stable sinus rhythm. However, it is a potentially dangerous invasive procedure with potentially fatal complications.
Comparison: External cardioversion vs. catheter ablation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | catheter ablation to treat persistent atrial fibrillation |
|
| 2 | Experimental | cardioversion and drug prophylaxis to treat persistent atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| catheter ablation | Procedure | catheter ablation to treat persistent atrial fibrillation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival after 6 months (i.e. freedom of atrial tachyarrhythmias - as evaluated in a 7-d-holter, stroke, pulmonary vein stenosis - as evaluated in a CT-/MRT-scan 6 months after the initial procedure - and death). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| success-rate immediately after intervention | success-rate immediately after intervention | |
| need for re-intervention between 2 and 3 months after initial procedure if not stable sinus rhythm at the two-months follow-up (further ablation/cardioversion) | 2-3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heidi L Estner, MD | Contact | 0049 89 1218 2020 | estner@dhm.mhn.de |
| Name | Affiliation | Role |
|---|---|---|
| Isabel Deisenhofer, MD | Deutsches Herzzentrum Muenchen | Study Chair |
| Heidi L Estner, MD | Deutsches Herzzentrum Muenchen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum Muenchen | Recruiting | Munich | 80636 | Germany |
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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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| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
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| external electric cardioversion |
| Procedure |
external cardioversion and drug prophylaxis to treat persistent atrial fibrillation |
|
| burden of atrial fibrillation in a 7-day-holter after 6 months | 6 months |
| significant improvement in exercise capacity (measured by spiroergometry) | 6 months |
| decrease in NT-pro-BNP levels in the blood after 6 months compared to the level before initial intervention | 6 months |
| improvement of quality-of-life (combined questionnaire including the SF-36 form) before initial intervention and at the 6-months follow-up | 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |