Persistent Atrial FibrillationIRON-ICENCT03365700
Cryoballon Versus Radiofrequency Ablation for Persistent Atrial Fibrillation
A study testing Radiofrequency Ablation and Cryoballoon ablation in people with Persistent Atrial Fibrillation, run by Luigi Sacco University Hospital at 3 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Radiofrequency Ablation and Cryoballoon ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Feb 2018to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure
- Age range of 18 - 85 years
- 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.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"
Milan
Giovanni B Forleo, MD, PhD, gbforleo@gmail.com
- Not yet recruiting
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
Milan
Claudio Tondo, Professor
Gaetano Fassini, MD
- Not yet recruiting
Istituto Clinico S. Ambrogio
Milan
Massimo Mantica, MD
About this study
Official title: 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.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Radiofrequency Ablation, Cryoballoon ablation
- Keywords
- Persistent atrial fibrillation, Catheter ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationProcedure or surgery
Also called Pulmonary vein isolation
Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
Cryoballoon ablationProcedure or surgery
Also called Pulmonary vein isolation
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.
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon ablation | Active comparator | Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Receives: Procedure: Cryoballoon ablation |
| Radiofrequency Ablation | Active comparator | Contact force-sensing radiofrequency left atrial ablation with 3D mapping system. Receives: Procedure: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial tachycardia/fibrillation
Freedom from atrial tachycardia/fibrillation within 12 months after CA. Arrhythmias had to last 30 seconds or more to be considered present.
Measured: 12 months
Secondary outcomes (16)
Number of AF episodes recorded.
Measured: 12 months
Duration of AF episodes recorded.
Measured: 12 months
Length of postoperative hospital stay.
Measured: 1 month
Total procedural time.
Measured: 1 day
Fluoroscopy time
Measured: 1 day
Left atrial instrumentation time
total time during which there are catheters in the LA
Measured: 1 day
Hospitalizations after discharge.
number of hospitalizations after discharge
Measured: 12 months
Procedure-related complications
Complications: cerebrovascular (thromboembolic or hemorrhagic), cardiovascular (cardiac perforation, tamponade) or gastrointestinal.
Measured: 1 week
Incidence of cerebrovascular events from the time of the operation up to 90 days.
Measured: 90 Days
Long-term success
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.
Measured: 36 months
Freedom from clinical or stroke-relevant AF/AFL/AT.
Freedom from AF/AFL/AT with duration cutoff > 1 hour
Measured: 12 months
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)
Freedom from AF/AFL/AT with duration cutoff > 7 days
Measured: 12 months
Regression from persistent to non-paroxysmal atrial fibrillation
Patients converted into paroxysmal forms of AF.
Measured: 12 months
Significant reduction in AF burden
>75% reduction from pre- to postablation and/or total postablation burden <12%
Measured: 12 months
Low daily AF burden
Patients with AF burden less than 1%- 2%
Measured: 12 months
Death from any cause
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Feb 2018
- Primary completionMar 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Cardiologico Monzino
- Responsible party
- Principal investigator, Giovanni B Forleo, Luigi Sacco University Hospital
- Investigators
- Claudio Tondo, MD, PhD, Principal investigator, Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365700
- Sponsor's protocol ID
- IRON2017
- Acronym
- IRON-ICE
- Status last verified
- Feb 2018
- First submitted
- 17 Nov 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27381589Kuck 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.
PubMed 27042964
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoballon Versus Conventional Radiofrequency Ablation for Persistent Atrial Fibrillation With AF Duration < 2 Years: the IRON-ICE Trial
- ClinicalTrials.gov ID
- NCT03365700
- Acronym / sponsor ID
- IRON-ICE / IRON2017
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Persistent atrial fibrillation, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Collaborators
- Centro Cardiologico Monzino
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon ablation | Active comparator | Procedure: Cryoballoon ablationCryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. |
| Radiofrequency Ablation | Active comparator | Procedure: Radiofrequency AblationContact force-sensing radiofrequency left atrial ablation with 3D mapping system. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
- Patients presenting with Persistent AF with AF duration < 2 years scheduled to undergo a PVAI procedure
- Age range of 18 - 85 years
- 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.
- Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Key exclusion criteria (6 listed)
- 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.-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency AblationAlso: Pulmonary vein isolationLeft atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter. | Procedure or surgery | Radiofrequency Ablation |
| Cryoballoon ablationAlso: Pulmonary vein isolationCryoballoon 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. | Procedure or surgery | Cryoballoon ablation |
Primary outcome
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.
16 secondary outcomes
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
Hospitalizations after discharge.
Time frame: 12 months
Procedure-related complications
Time frame: 1 week
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 clinical or stroke-relevant AF/AFL/AT.
Time frame: 12 months
Freedom from persistent AF/AFL/AT (duration cutoff of 7 days)
Time frame: 12 months
Regression from persistent to non-paroxysmal atrial fibrillation
Time frame: 12 months
Significant reduction in AF burden
Time frame: 12 months
Low daily AF burden
Time frame: 12 months
Death from any cause
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Results publication: PubMed 27381589Kuck 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.
- Results publication: PubMed 27042964Kuck 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudio Tondo, MD, PhD principal investigator
Heart Rhythm Center at Monzino Cardiac Center, IRCCS.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation and Cryoballoon ablation in people with Persistent Atrial Fibrillation, run by Luigi Sacco University Hospital at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni B Forleo, MD, PhD (+390239042789, gbforleo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial tachycardia/fibrillation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365700, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.