Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
IRON-ICE
Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
1 other identifier
interventional
303
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2017
CompletedFirst Posted
Study publicly available on registry
December 7, 2017
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedFebruary 23, 2018
February 1, 2018
1.1 years
November 17, 2017
February 21, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (16)
Number of AF episodes recorded.
12 months
Duration of AF episodes recorded.
12 months
Length of postoperative hospital stay.
1 month
Total procedural time.
1 day
Fluoroscopy time
1 day
- +11 more secondary outcomes
Study Arms (2)
Cryoballoon ablation
ACTIVE COMPARATORCryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.
Radiofrequency Ablation
ACTIVE COMPARATORContact force-sensing radiofrequency left atrial ablation with 3D mapping system.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luigi Sacco University Hospitallead
- Centro Cardiologico Monzinocollaborator
Study Sites (3)
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan, Italy
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
Milan, Italy
Istituto Clinico S. Ambrogio
Milan, Italy
Related Publications (2)
Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
PMID: 27381589RESULTKuck KH, Brugada J, Furnkranz 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;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
PMID: 27042964RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Claudio Tondo, MD, PhD
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section Head Electrophysiology and Cardiac Pacing.
Study Record Dates
First Submitted
November 17, 2017
First Posted
December 7, 2017
Study Start
February 1, 2018
Primary Completion
March 1, 2019
Study Completion
August 1, 2020
Last Updated
February 23, 2018
Record last verified: 2018-02