FIRE AND ICE II Trial Pilot

Medtronic

Status: Completed

Conditions: Persistent Atrial Fibrillation; Atrial Arrhythmia

Treatments: Device: Radiofrequency Catheter (ThermoCool Smarttouch); Device: Cryoballoon (Arctic Front Advance Cryoballoon)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03706677

MDT17037

Details and patient eligibility

About

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).

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 2 patient groups

CRYO group

Active Comparator group

Description:

Within the CRYO arm the ablation will be performed using the Arctic Front Advance Cardiac CryoAblation Catheter, including next generation systems as applicable and approved by Medtronic for the trial. Intervention performed: Cryoballoon ablation; Cryoballoon (Arctic Front Advance Cryoballoon)

Treatment:

Device: Cryoballoon (Arctic Front Advance Cryoballoon)

RF group

Active Comparator group

Description:

Within the RF arm the ablation will be performed using a catheter out of the ThermoCool Smarttouch catheter family, including next generation contact force systems as applicable. Intervention performed: Radiofrequency ablation; Radiofrequency Catheter (ThermoCool Smarttouch)

Treatment:

Device: Radiofrequency Catheter (ThermoCool Smarttouch)