BENITIONSClinical Trial Intelligence

FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

단계 해당 없음 완료 NCT01490814

대상 질환Symptomatic Paroxysmal Atrial Fibrillation
임상 단계단계 해당 없음
스폰서Medtronic Cardiac Ablation Solutions
상태완료
참여자 수769 명
중재(약물)Electrical isolation of the pulmonary veins, Electrical isolation of pulmonary veins
시작일2011년 12월
완료일2016년 1월
결과 공개일2018년 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

33 months · Participants

Cryoballoon Ablation138 Participants
Radiofrequency Ablation143 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.

33 months · Participants

Cryoballoon Ablation334 Participants
Radiofrequency Ablation325 Participants
Cryoballoon Ablation2 Participants
Radiofrequency Ablation0 Participants
Cryoballoon Ablation2 Participants
Radiofrequency Ablation2 Participants

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