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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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 ]
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
|Contact: Giovanni B Forleo, MD, PhDemail@example.com|
|Azienda Ospedaliera - Polo Universitario - "Luigi Sacco"||Recruiting|
|Contact: Giovanni B Forleo, MD, PhD firstname.lastname@example.org|
|Heart Rhythm Center at Monzino Cardiac Center, IRCCS.||Not yet recruiting|
|Contact: Claudio Tondo, Professor|
|Sub-Investigator: Gaetano Fassini, MD|
|Istituto Clinico S. Ambrogio||Not yet recruiting|
|Contact: Massimo Mantica, MD|
|Principal Investigator:||Claudio Tondo, MD, PhD||Heart Rhythm Center at Monzino Cardiac Center, IRCCS.|