FIRE AND ICE II Trial Pilot

  • STATUS
    Recruiting
  • End date
    May 30, 2025
  • participants needed
    60
  • sponsor
    Medtronic Cardiac Rhythm and Heart Failure
Updated on 24 March 2022
fibrillation
radiofrequency ablation
catheter ablation
antiarrhythmic drug
cardioversion
persistent atrial fibrillation

Summary

The FIRE AND ICE II Trial (Pilot) is the pilot phase of a prospective, randomized, single-blinded, multi-center, interventional post-market clinical trial, comparing efficacy and safety of isolation of the pulmonary veins (PVI) using a Cryoballoon catheter or radiofrequency ablation with a ThermoCool® Smarttouch® catheter in subjects with persistent atrial fibrillation (AF).

Description

60 patients with persistent AF will be randomized 1:1 between Cryoballoon ablation and Radiofrequency ablation in the FIRE AND ICE II Trial Pilot at 5 clinical sites in Europe.

The data collected within the pilot phase will be reviewed and a decision on extending the trial with an extended number of patients and sites as main phase will be taken.

Details
Condition Persistent Atrial Fibrillation, Atrial Arrhythmia
Treatment Cryoballoon (Arctic Front Advance Cryoballoon), Radiofrequency Catheter (ThermoCool Smarttouch)
Clinical Study IdentifierNCT03706677
SponsorMedtronic Cardiac Rhythm and Heart Failure
Last Modified on24 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Documentation of symptomatic persistent AF (following the European Society of Cardiology (ESC) guideline 2016) defined as: Persistent AF - AF that lasts longer than 7 days, including episodes that are terminated by cardioversion, either with drugs or by direct current cardioversion, after 7 days or more
Date of first diagnosis of persistent AF within the last 12 months preceding the date of screening
Documented treatment failure or intolerance of at least one Class I or Class III antiarrhythmic drug

Exclusion Criteria

Known pre-existing hemi-diaphragmatic paralysis
Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
History of right atrial flutter, not ablated prior to enrollment
Any cardiac surgery, myocardial infarction, percutaneous coronary intervention or coronary artery stenting which occurred within the 3 months before the eligibility assessment
Unstable angina pectoris
Primary pulmonary hypertension
Any condition contraindicating chronic anticoagulation
Any cerebral ischemic event (stroke or transient ischemic attack [TIA]) which occurred within the 6 months before the consent date
Presence of any cardiac prosthetic valves
Long-standing persistent AF lasting for ≥ 1 year (even when it is decided to adopt a rhythm control strategy)
New York Health Association (NYHA) class III or IV heart failure and/or documented left ventricular ejection fraction (LVEF) < 40% measured by acceptable cardiac testing (e.g. TTE)
Acute cardiac condition, including endocarditis, pericarditis or pericardial effusion
Presence or likely implant of a permanent pacemaker, biventricular pacemaker or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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