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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
303

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Luigi Sacco University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Cardiologico Monzino

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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