FIRE AND ICE II Trial Pilot
- Conditions
- Persistent Atrial FibrillationAtrial Arrhythmia
- Interventions
- Device: Cryoballoon (Arctic Front Advance Cryoballoon)Device: Radiofrequency Catheter (ThermoCool Smarttouch)
- Registration Number
- NCT03706677
- Lead Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CRYO group Cryoballoon (Arctic Front Advance Cryoballoon) 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) RF group Radiofrequency Catheter (ThermoCool Smarttouch) 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)
- Primary Outcome Measures
Name Time Method Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure) 12 Month To demonstrate that Cryo ablation is non-inferior to radiofrequency (RF) ablation with respect to time to clinical treatment failure, defined as recurrence of atrial arrhythmias or intervention for AF (a blanking period of three months will be maintained after the index procedure). The first documented recurrence of an episode of atrial arrhythmia after the blanking period lasting at least 30 seconds will be counted for the primary efficacy objective, as well as any intervention for AF with initiation after the blanking period.
Safety Objective (freedom from device and procedure related serious adverse events (SAEs)) 12 Month To demonstrate that Cryo ablation is non-inferior to RF ablation with respect to freedom from device and procedure related serious adverse events (SAEs). The first device or procedure related serious adverse event with onset after start of the index ablation therapy will be used for the safety objective analysis.
- Secondary Outcome Measures
Name Time Method Evaluate post-procedural interventions for atrial arrhythmias 12 Month and 36 Month Post-procedural interventions for atrial arrhythmias will be collected and reported.
Assess quality of life: EQ-5D-5L 12 Month and 36 Month The EQ-5D-5L and AFEQT questionnaires are administered at screening / baseline and at scheduled follow-up (FU) visits. The EQ-5D-5L questionnaire includes 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) assessed with descriptive questions, and a general health score assessed on a Visual Analogue Scale (VAS). For the EQ-5D-5L an index will be derived by comparing the responses to a value set. The index and the health score will each be summarized with mean and standard deviation for randomized arms by visit. The AFEQT questionnaire is a 20-item questionnaire that supports a 4-item symptoms score, an 8-item daily activity score, a 6-item treatment concerns score, and a 2-item treatment satisfaction scale. These are combined into a single AFEQT score. The sub-scores and summary score will be summarized by subject visit and post-procedure assessments, as well as compared between randomized arms using a mixed regression model.
Characterize AF burden data seen on Reveal LINQ in subjects with any post-procedural intervention for AF 12 Month and 36 Month For subjects in the pilot phase, post-ablation AF burden from the Cardiac Compass of the Reveal LINQ device will be characterized who had a post-procedural intervention for AF.
Evaluate the relation between outcome and AF burden in the 4 weeks before ablation (Reveal LINQ will be assessed) 3 Month For subjects in the pilot phase, the relation between freedom from AF as assessed for the first primary objective, and the average AF burden from the 4 weeks before the ablation procedure as measured by the Reveal LINQ will be assessed
Assess acute procedural success (PVI) 3 Month Acute procedural success is defined as successful electrical isolation of the pulmonary veins after the ablation procedure as assessed via a diagnostic catheter.
Evaluate incidence rate of post-procedure events 12 Month and 36 Month Serious, device-related, and procedure-related adverse events, all-cause and cardio-vascular-related (CV) hospitalizations, all-cause and CV-related mortality, transient ischemic attack and stroke, phrenic nerve palsy, AF-related symptoms and prescription of antiarrhythmic medication will be reported separately.
Characterize AF burden seen on Reveal LINQ 12 Month and 36 Month For subjects in the pilot phase, AF burden will be determined before and after the index ablation from the Cardiac Compass of the Reveal LINQ device.
Comparison of the lesion area as measured by cardiac MRI at Month 3 3 Month For subjects in the pilot phase, the MRI Core Lab will determine the area of the atrial lesion created by the PVI procedure. Lesion area will be compared between arms of the trial.
Trial Locations
- Locations (5)
Clinique Pasteur Toulouse
🇫🇷Toulouse, Cedex 3, France
Asklepios St. Georg
🇩🇪Hamburg, Germany
Herz-Zentrum Bad Krozingen
🇩🇪Bad Krozingen, Germany
Cardioangiologisches Centrum Bethanien CCB
🇩🇪Frankfurt am Main, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck
🇩🇪Lübeck, Germany