Clinical trial NCT03706677: FIRE AND ICE II Trial Pilot
Official title: FIRE AND ICE II Trial Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Atrial Fibrillation
Atrial Arrhythmia
Keywords: Ablation
Cryoballoon
Radiofrequency
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: genae associates (CRO), Antwerp, Belgium
name: King's College London
name: Deutsches Herzzentrum Muenchen
First posted: 2018-10-16
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization 1:1 between Cryoballoon ablation and Radiofrequency ablation
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: Key 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

Key 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

Primary outcomes:
measure: Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)
timeFrame: 12 Month
measure: Safety Objective (freedom from device and procedure related serious adverse events (SAEs))
timeFrame: 12 Month
Secondary outcomes:
measure: Assess acute procedural success (PVI)
timeFrame: 3 Month
measure: Assess quality of life: EQ-5D-5L
timeFrame: 12 Month and 36 Month
measure: Evaluate post-procedural interventions for atrial arrhythmias
timeFrame: 12 Month and 36 Month
measure: Evaluate incidence rate of post-procedure events
timeFrame: 12 Month and 36 Month
measure: Characterize AF burden seen on Reveal LINQ
timeFrame: 12 Month and 36 Month
measure: Characterize AF burden data seen on Reveal LINQ in subjects with any post-procedural intervention for AF
timeFrame: 12 Month and 36 Month
measure: Comparison of the lesion area as measured by cardiac MRI at Month 3
timeFrame: 3 Month
measure: Evaluate the relation between outcome and AF burden in the 4 weeks before ablation (Reveal LINQ will be assessed)
timeFrame: 3 Month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
state: Cedex 3
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Frankfurt am Main
country: Germany
facility: Cardioangiologisches Centrum Bethanien CCB
city: Hamburg
country: Germany
facility: Asklepios St. Georg
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein / Campus Lübeck
Study officials:
affiliation: Asklepios St. Georg, Hamburg
name: Karl-Heinz Kuck, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: