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

February 21, 2018 updated by: Giovanni B Forleo, Luigi Sacco University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy
        • Recruiting
        • Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
        • Contact:
      • Milano, Italy
        • Not yet recruiting
        • Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
        • Contact:
          • Claudio Tondo, Professor
        • Sub-Investigator:
          • Gaetano Fassini, MD
      • Milano, Italy
        • Not yet recruiting
        • Istituto Clinico S. Ambrogio
        • Contact:
          • Massimo Mantica, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Sacco University Hospital

Collaborators

Centro Cardiologico Monzino

Investigators

  • Principal Investigator: Claudio Tondo, MD, PhD, Heart Rhythm Center at Monzino Cardiac Center, IRCCS.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

November 17, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRON2017

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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