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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Biosense Webster, Inc. | INDUSTRY |
| Abbott Medical Devices | INDUSTRY |
| Guidant Corporation |
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study patients with symptomatic paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. The primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Both segmental, ostial and circumferential, extra-ostial pulmonary vein (PV) isolation have been proven effective in the treatment of atrial fibrillation.
In this study with symptomativ paroxystic or persistent AF were randomised to one of the above mentioned ablation methods. Each patient was allowed a maximum of two ablation procedures. Holter monitoring for 14-days periods will be performed at 3 months after ablation. The patiens are seen at out-patient visits at 1, 3, 6, 9, and 12 months after the ablation procedure.
Primary endpoints were recurrent AF and recurrence of left atrium-PV conduction.
Secondary endpoints were:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter ablation (pulmonary vein isolation) | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| overall efficacy (= freedom from symptomatic, ECG documented AF or organized LA tachycardia (with a duration of > 10 min) without receiving antiarrhythmic medication) |
| Measure | Description | Time Frame |
|---|---|---|
| - safety | ||
| - resumption of LA-PV conduction | ||
| - neurohormones |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Nilsson, MD | Rigshospitalet, Denmark | Principal Investigator |
| Xu Chen, MD | Righospitalet, Copenhagen, Denmark | Principal Investigator |
| Steen M Pehrson, MD | Righospitalet, Copenhagen, Denmark | Principal Investigator |
| Lars Køber, MD | Righospitalet, Copenhagen, Denmark | Principal Investigator |
| Jørgen Hilden, MD | Department of biostatistics, University of Copenhagen | Principal Investigator |
| Jesper H Svendsen, MD | Righospitalet, Copenhagen, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Righospitalet, Copenhagen University Hospital | Copenhagen | DK-2199 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15505091 | Background | Oral H, Chugh A, Lemola K, Cheung P, Hall B, Good E, Han J, Tamirisa K, Bogun F, Pelosi F Jr, Morady F. Noninducibility of atrial fibrillation as an end point of left atrial circumferential ablation for paroxysmal atrial fibrillation: a randomized study. Circulation. 2004 Nov 2;110(18):2797-801. doi: 10.1161/01.CIR.0000146786.87037.26. Epub 2004 Oct 25. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| INDUSTRY |
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| - socio-economics (cost effectiveness) |
| - inflammatory markers |
| - quality of life |
| - signal averaged P wave signals- |
| D013514 |
| Surgical Procedures, Operative |