Clinical trial NCT03365700: Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
Official title: Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: Persistent atrial fibrillation
Catheter ablation
Lead sponsor: Luigi Sacco University Hospital
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
First posted: 2017-12-07
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Freedom from atrial tachycardia/fibrillation
timeFrame: 12 months
Secondary outcomes:
measure: Number of AF episodes recorded.
timeFrame: 12 months
measure: Duration of AF episodes recorded.
timeFrame: 12 months
measure: Length of postoperative hospital stay.
timeFrame: 1 month
measure: Total procedural time.
timeFrame: 1 day
measure: Fluoroscopy time
timeFrame: 1 day
measure: Left atrial instrumentation time
timeFrame: 1 day
measure: Hospitalizations after discharge.
timeFrame: 12 months
measure: Procedure-related complications
timeFrame: 1 week
measure: Incidence of cerebrovascular events from the time of the operation up to 90 days.
timeFrame: 90 Days
measure: Long-term success
timeFrame: 36 months
measure: Freedom from clinical or stroke-relevant AF/AFL/AT.
timeFrame: 12 months
measure: Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)
timeFrame: 12 months
measure: Regression from persistent to non-paroxysmal atrial fibrillation
timeFrame: 12 months
measure: Significant reduction in AF burden
timeFrame: 12 months
measure: Low daily AF burden
timeFrame: 12 months
measure: Death from any cause
timeFrame: 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
city: Milano
country: Italy
facility: Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
city: Milano
country: Italy
facility: Istituto Clinico S. Ambrogio
Study officials:
affiliation: Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
name: Claudio Tondo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kuck 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.