FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Не применимо
Завершено
NCT01490814
| Заболевание | Symptomatic Paroxysmal Atrial Fibrillation |
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| Фаза | Не применимо |
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| Спонсор | Medtronic Cardiac Ablation Solutions |
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| Статус | Завершено |
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| Участники | 769 участн. |
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| Вмешательство | Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins |
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| Дата начала | 12.2011 |
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| Дата завершения | 01.2016 |
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| Публикация результатов | 2.11.2018 |
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Кратко
Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.
Number of Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure
33 months · Participants
| Cryoballoon Ablation | 138 Participants |
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| Radiofrequency Ablation | 143 Participants |
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Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest.
33 months · Participants
| Cryoballoon Ablation | 334 Participants |
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| Radiofrequency Ablation | 325 Participants |
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| Cryoballoon Ablation | 2 Participants |
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| Radiofrequency Ablation | 0 Participants |
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| Cryoballoon Ablation | 2 Participants |
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| Radiofrequency Ablation | 2 Participants |
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