Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial

Luigi Sacco University Hospital3 sites in 1 country303 target enrollmentFebruary 1, 2018

ConditionsPersistent Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Persistent Atrial Fibrillation
Sponsor: Luigi Sacco University Hospital
Enrollment: 303
Locations: 3
Primary Endpoint: Freedom from atrial tachycardia/fibrillation
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 1, 2018

End Date

August 2020

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Luigi Sacco University Hospital

Responsible Party

Principal Investigator

Giovanni B Forleo

Section Head Electrophysiology and Cardiac Pacing.

Luigi Sacco University Hospital

Eligibility Criteria

Inclusion Criteria

•Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
•Patients presenting with Persistent AF with AF duration \< 2 years scheduled to undergo a PVAI procedure
•Age range of 18 - 85 years
•Patients with already implanted devices with AF detection capabilities (for clinical indications): ILR implanted in the same hospital stay or within 6 months before the ablation or patients with an dual chamber PM, ICD or CRTD and an existing functional atrial lead.
•Patients must be able and willing to provide written informed consent to participate in the clinical trial.

Exclusion Criteria

•Congenital heart disease, age younger than 18 years, significant valve disease, LA size \>55 mm, and severe heart failure (ejection fraction \< 30% and/or New York Heart Association class IV).
•Presence of a mechanical prosthetic valve.
•Secondary causes of atrial fibrillation
•Documented intra-atrial thrombus or another abnormality which precludes catheter introduction.
•Social factors that would preclude follow up or make compliance difficult.-
•Patients who are or may potentially be pregnant Previous left atrial catheter ablation or MAZE procedure.

Outcomes

Primary Outcomes

Freedom from atrial tachycardia/fibrillation

Time Frame: 12 months

Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.

Secondary Outcomes

Length of postoperative hospital stay.(1 month)
Total procedural time.(1 day)
Significant reduction in AF burden(12 months)
Number of AF episodes recorded.(12 months)
Left atrial instrumentation time(1 day)
Incidence of cerebrovascular events from the time of the operation up to 90 days.(90 Days)
Death from any cause(12 months)
Low daily AF burden(12 months)
Duration of AF episodes recorded.(12 months)
Fluoroscopy time(1 day)
Procedure-related complications(1 week)
Long-term success(36 months)
Hospitalizations after discharge.(12 months)
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)(12 months)
Freedom from clinical or stroke-relevant AF/AFL/AT.(12 months)
Regression from persistent to non-paroxysmal atrial fibrillation(12 months)