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

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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

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.


Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Radiofrequency Ablation Procedure: Cryoballoon ablation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cryoballoon ablation
Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line.
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: Radiofrequency Ablation
Contact force-sensing radiofrequency left atrial ablation with 3D mapping system.
Procedure: Radiofrequency Ablation
Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
Other Name: Pulmonary vein isolation



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of AF episodes recorded. [ Time Frame: 12 months ]
  2. Duration of AF episodes recorded. [ Time Frame: 12 months ]
  3. Length of postoperative hospital stay. [ Time Frame: 1 month ]
  4. Total procedural time. [ Time Frame: 1 day ]
  5. Fluoroscopy time [ Time Frame: 1 day ]
  6. Left atrial instrumentation time [ Time Frame: 1 day ]
    total time during which there are catheters in the LA

  7. Hospitalizations after discharge. [ Time Frame: 12 months ]
    number of hospitalizations after discharge

  8. Procedure-related complications [ Time Frame: 1 week ]
    Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.

  9. Incidence of cerebrovascular events from the time of the operation up to 90 days. [ Time Frame: 90 Days ]
  10. 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.

  11. Freedom from clinical or stroke-relevant AF/AFL/AT. [ Time Frame: 12 months ]
    Freedom from AF/AFL/AT with duration cutoff > 1 hour

  12. 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

  13. Regression from persistent to non-paroxysmal atrial fibrillation [ Time Frame: 12 months ]
    Patients converted into paroxysmal forms of AF.

  14. Significant reduction in AF burden [ Time Frame: 12 months ]
    >75% reduction from pre- to postablation and/or total postablation burden <12%

  15. Low daily AF burden [ Time Frame: 12 months ]
    Patients with AF burden less than 1%- 2%

  16. Death from any cause [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365700


Contacts
Contact: Giovanni B Forleo, MD, PhD +390239042789 gbforleo@gmail.com

Locations
Italy
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco" Recruiting
Milano, Italy
Contact: Giovanni B Forleo, MD, PhD       gbforleo@gmail.com   
Heart Rhythm Center at Monzino Cardiac Center, IRCCS. Not yet recruiting
Milano, Italy
Contact: Claudio Tondo, Professor         
Sub-Investigator: Gaetano Fassini, MD         
Istituto Clinico S. Ambrogio Not yet recruiting
Milano, Italy
Contact: Massimo Mantica, MD         
Sponsors and Collaborators
Luigi Sacco University Hospital
Centro Cardiologico Monzino
Investigators
Principal Investigator: Claudio Tondo, MD, PhD Heart Rhythm Center at Monzino Cardiac Center, IRCCS.

Publications of Results:
Responsible Party: Giovanni B Forleo, Section Head Electrophysiology and Cardiac Pacing., Luigi Sacco University Hospital
ClinicalTrials.gov Identifier: NCT03365700     History of Changes
Other Study ID Numbers: IRON2017
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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

Keywords provided by Giovanni B Forleo, Luigi Sacco University Hospital:
Persistent atrial fibrillation
Catheter ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes