Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

Persistent Atrial Fibrillation Clinical Trial

— IRON-ICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03365700
• Other study ID #: IRON2017
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2017
• Last updated: February 21, 2018
• Start date: February 1, 2018
• Est. completion date: August 2020

Study information

• Verified date: February 2018
• Source: Luigi Sacco University Hospital
• Contact: Giovanni B Forleo, MD, PhD
• Phone: +390239042789
• Email: gbforleo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 303
• Est. completion date: August 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

Procedure:
• Radiofrequency Ablation
Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
• Cryoballoon ablation
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.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"	Milano
Italy	Heart Rhythm Center at Monzino Cardiac Center, IRCCS.	Milano
Italy	Istituto Clinico S. Ambrogio	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Luigi Sacco University Hospital	Centro Cardiologico Monzino

Country where clinical trial is conducted

Italy, 

References & Publications (2)

Kuck KH, Brugada J, Fürnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9 — View Citation

Kuck KH, Fürnkranz A, Chun KR, Metzner A, Ouyang F, Schlüter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kühne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal a — View Citation

Outcome

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