A randomized trial has recently demonstrated non-inferiority of cryoballoon vs. radiofrequency (RF) catheter ablation in patients with drug-refractory paroxysmal atrial fibrillation (AF). There is a growing amount of evidence suggesting that Cryoballoon ablation is highly effective also in non-paroxysmal atrial fibrillation. The IRON-ICE trial will evaluate the effect of Cryoballoon AF ablation in patients with short-term persistent AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
303
Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan, Italy
RECRUITINGHeart Rhythm Center at Monzino Cardiac Center, IRCCS.
Milan, Italy
NOT_YET_RECRUITINGIstituto Clinico S. Ambrogio
Milan, Italy
NOT_YET_RECRUITINGFreedom from atrial tachycardia/fibrillation
Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.
Time frame: 12 months
Number of AF episodes recorded.
Time frame: 12 months
Duration of AF episodes recorded.
Time frame: 12 months
Length of postoperative hospital stay.
Time frame: 1 month
Total procedural time.
Time frame: 1 day
Fluoroscopy time
Time frame: 1 day
Left atrial instrumentation time
total time during which there are catheters in the LA
Time frame: 1 day
Hospitalizations after discharge.
number of hospitalizations after discharge
Time frame: 12 months
Procedure-related complications
Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
Time frame: 1 week
Incidence of cerebrovascular events from the time of the operation up to 90 days.
Time frame: 90 Days
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Long-term success
freedom from AF/AFL/AT recurrences following the 3-month blanking period within 36-month follow-up from the date of the ablation procedure in the absence of Class I and III antiarrhythmic drug therapy.
Time frame: 36 months
Freedom from clinical or stroke-relevant AF/AFL/AT.
Freedom from AF/AFL/AT with duration cutoff \> 1 hour
Time frame: 12 months
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)
Freedom from AF/AFL/AT with duration cutoff \> 7 days
Time frame: 12 months
Regression from persistent to non-paroxysmal atrial fibrillation
Patients converted into paroxysmal forms of AF.
Time frame: 12 months
Significant reduction in AF burden
\>75% reduction from pre- to postablation and/or total postablation burden \<12%
Time frame: 12 months
Low daily AF burden
Patients with AF burden less than 1%- 2%
Time frame: 12 months
Death from any cause
Time frame: 12 months