ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03365700
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Centro Cardiologico Monzino
Information provided by (Responsible Party):
Giovanni B Forleo, Luigi Sacco University Hospital

November 17, 2017
December 7, 2017
February 23, 2018
February 1, 2018
March 2019   (Final data collection date for primary outcome measure)
Freedom from atrial tachycardia/fibrillation [ Time Frame: 12 months ]
Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.
Freedom from atrial tachycardia/fibrillation [ Time Frame: 12 months ]
The primary end point is defined as freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.
Complete list of historical versions of study NCT03365700 on ClinicalTrials.gov Archive Site
  • Number of AF episodes recorded. [ Time Frame: 12 months ]
  • Duration of AF episodes recorded. [ Time Frame: 12 months ]
  • Length of postoperative hospital stay. [ Time Frame: 1 month ]
  • Total procedural time. [ Time Frame: 1 day ]
  • Fluoroscopy time [ Time Frame: 1 day ]
  • Left atrial instrumentation time [ Time Frame: 1 day ]
    total time during which there are catheters in the LA
  • Hospitalizations after discharge. [ Time Frame: 12 months ]
    number of hospitalizations after discharge
  • Procedure-related complications [ Time Frame: 1 week ]
    Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
  • Incidence of cerebrovascular events from the time of the operation up to 90 days. [ Time Frame: 90 Days ]
  • Long-term success [ Time Frame: 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.
  • Freedom from clinical or stroke-relevant AF/AFL/AT. [ Time Frame: 12 months ]
    Freedom from AF/AFL/AT with duration cutoff > 1 hour
  • Freedom from persistent AF/AFL/AT (duration cutoff of 7 days) [ Time Frame: 12 months ]
    Freedom from AF/AFL/AT with duration cutoff > 7 days
  • Regression from persistent to non-paroxysmal atrial fibrillation [ Time Frame: 12 months ]
    Patients converted into paroxysmal forms of AF.
  • Significant reduction in AF burden [ Time Frame: 12 months ]
    >75% reduction from pre- to postablation and/or total postablation burden <12%
  • Low daily AF burden [ Time Frame: 12 months ]
    Patients with AF burden less than 1%- 2%
  • Death from any cause [ Time Frame: 12 months ]
  • Number of AF episodes recorded. [ Time Frame: 12 months ]
  • Duration of AF episodes recorded. [ Time Frame: 12 months ]
  • Length of postoperative hospital stay. [ Time Frame: 1 month ]
  • Total procedural time. [ Time Frame: 1 day ]
  • Fluoroscopy time [ Time Frame: 1 day ]
  • Left atrial instrumentation time [ Time Frame: 1 day ]
    total time during which there are catheters in the LA
  • Hospitalizations after discharge. [ Time Frame: 12 months ]
    number of hospitalizations after discharge
  • Procedure-related complications [ Time Frame: 1 week ]
    Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
  • Incidence of cerebrovascular events from the time of the operation up to 90 days. [ Time Frame: 90 Days ]
Not Provided
Not Provided
 
Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Persistent Atrial Fibrillation
  • Procedure: Radiofrequency Ablation
    Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
    Other Name: Pulmonary vein isolation
  • Procedure: 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.
    Other Name: Pulmonary vein isolation
  • Active Comparator: Cryoballoon ablation
    Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.
    Intervention: Procedure: Cryoballoon ablation
  • Active Comparator: Radiofrequency Ablation
    Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.
    Intervention: Procedure: Radiofrequency Ablation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
303
Same as current
August 2020
March 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Older Adult)
No
Contact: Giovanni B Forleo, MD, PhD +390239042789 gbforleo@gmail.com
Italy
 
 
NCT03365700
IRON2017
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Not Provided
Giovanni B Forleo, Luigi Sacco University Hospital
Luigi Sacco University Hospital
Centro Cardiologico Monzino
Principal Investigator: Claudio Tondo, MD, PhD Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
Luigi Sacco University Hospital
February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP