Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

Not Applicable

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Cryoballoon ablation; Procedure: Radiofrequency Ablation

• Registration Number: NCT03365700
• Lead Sponsor: Luigi Sacco University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-17
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-07
• Status Verified: 2018-02
• Study Start: 2018-02-01
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-23
• Primary Completion: 2019-03
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 303

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoballoon ablation	Cryoballoon ablation	Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.
Radiofrequency Ablation	Radiofrequency Ablation	Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.

Primary Outcome Measures

Name	Time	Method
Freedom from atrial tachycardia/fibrillation	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 Outcome Measures

Name	Time	Method
Length of postoperative hospital stay.	1 month
Total procedural time.	1 day
Significant reduction in AF burden	12 months	\>75% reduction from pre- to postablation and/or total postablation burden \<12%
Number of AF episodes recorded.	12 months
Left atrial instrumentation time	1 day	total time during which there are catheters in the LA
Incidence of cerebrovascular events from the time of the operation up to 90 days.	90 Days
Death from any cause	12 months
Duration of AF episodes recorded.	12 months
Fluoroscopy time	1 day
Procedure-related complications	1 week	Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
Long-term success	36 months	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.
Low daily AF burden	12 months	Patients with AF burden less than 1%- 2%
Hospitalizations after discharge.	12 months	number of hospitalizations after discharge
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)	12 months	Freedom from AF/AFL/AT with duration cutoff \> 7 days
Freedom from clinical or stroke-relevant AF/AFL/AT.	12 months	Freedom from AF/AFL/AT with duration cutoff \> 1 hour
Regression from persistent to non-paroxysmal atrial fibrillation	12 months	Patients converted into paroxysmal forms of AF.

Trial Locations

Locations (3)

Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"; 🇮🇹 Milano, Italy

Heart Rhythm Center at Monzino Cardiac Center, IRCCS.; 🇮🇹 Milano, Italy

Istituto Clinico S. Ambrogio; 🇮🇹 Milano, Italy