FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
| 대상 질환 | Symptomatic Paroxysmal Atrial Fibrillation |
|---|---|
| 임상 단계 | 단계 해당 없음 |
| 스폰서 | Medtronic Cardiac Ablation Solutions |
| 상태 | 완료 |
| 참여자 수 | 769 명 |
| 중재(약물) | Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins |
| 시작일 | 2011년 12월 |
| 완료일 | 2016년 1월 |
| 결과 공개일 | 2018년 11월 2일 |
요약
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
| Cryoballoon Ablation | 138 Participants |
|---|---|
| Radiofrequency Ablation | 143 Participants |
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.
| Cryoballoon Ablation | 334 Participants |
|---|---|
| Radiofrequency Ablation | 325 Participants |
| Cryoballoon Ablation | 2 Participants |
| Radiofrequency Ablation | 0 Participants |
| Cryoballoon Ablation | 2 Participants |
| Radiofrequency Ablation | 2 Participants |
BENITIONS에서 보기 ClinicalTrials.gov 원문 보기
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