Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation (IRON-ICE)

Luigi Sacco University Hospital

Status: Unknown

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Cryoballoon ablation; Procedure: Radiofrequency Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03365700

IRON2017

Details and patient eligibility

About

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.

Enrollment: 303 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
2. Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure
3. Age range of 18 - 85 years
4. 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.
5. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

Cryoballoon ablation

Active Comparator group

Description:

Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.

Treatment:

Procedure: Cryoballoon ablation

Radiofrequency Ablation

Active Comparator group

Description:

Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.

Treatment:

Procedure: Radiofrequency Ablation