Back to resultsFIRE AND ICE II Trial Pilot
Primary Purpose
Persistent Atrial Fibrillation, Atrial Arrhythmia
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cryoballoon (Arctic Front Advance Cryoballoon)
Radiofrequency Catheter (ThermoCool Smarttouch)
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring Ablation, Cryoballoon, Radiofrequency
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
Sites / Locations
- Clinique Pasteur Toulouse
- Herz-Zentrum Bad Krozingen
- Cardioangiologisches Centrum Bethanien CCB
- Asklepios St. Georg
- Universitätsklinikum Schleswig-Holstein / Campus Lübeck
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
CRYO group
RF group
Arm 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)
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)
Outcomes
Primary Outcome Measures
Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)
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))
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
Assess acute procedural success (PVI)
Acute procedural success is defined as successful electrical isolation of the pulmonary veins after the ablation procedure as assessed via a diagnostic catheter.
Assess quality of life: EQ-5D-5L
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.
Evaluate post-procedural interventions for atrial arrhythmias
Post-procedural interventions for atrial arrhythmias will be collected and reported.
Evaluate incidence rate of post-procedure events
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
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.
Characterize AF burden data seen on Reveal LINQ in subjects with any post-procedural intervention for AF
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.
Comparison of the lesion area as measured by cardiac MRI at Month 3
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.
Evaluate the relation between outcome and AF burden in the 4 weeks before ablation (Reveal LINQ will be assessed)
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
Full Information
NCT ID
NCT03706677
First Posted
September 17, 2018
Last Updated
August 22, 2023
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
genae associates (CRO), Antwerp, Belgium, King's College London, Deutsches Herzzentrum Muenchen
1. Study Identification
Unique Protocol Identification Number
NCT03706677
Brief Title
FIRE AND ICE II Trial Pilot
Official Title
FIRE AND ICE II Trial Pilot
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 5, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Collaborators
genae associates (CRO), Antwerp, Belgium, King's College London, Deutsches Herzzentrum Muenchen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation, Atrial Arrhythmia
Keywords
Ablation, Cryoballoon, Radiofrequency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization 1:1 between Cryoballoon ablation and Radiofrequency ablation
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Single-blinded; participants will be blinded to the treatment group. Investigators will be blinded on study specific diagnostics used in the trial; Endpoint Review Committee will be blinded to the treatment group.
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRYO group
Arm Type
Active Comparator
Arm 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)
Arm Title
RF group
Arm Type
Active Comparator
Arm 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)
Intervention Type
Device
Intervention Name(s)
Cryoballoon (Arctic Front Advance Cryoballoon)
Intervention Description
Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)
Intervention Type
Device
Intervention Name(s)
Radiofrequency Catheter (ThermoCool Smarttouch)
Intervention Description
Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)
Primary Outcome Measure Information:
Title
Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)
Description
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.
Time Frame
12 Month
Title
Safety Objective (freedom from device and procedure related serious adverse events (SAEs))
Description
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.
Time Frame
12 Month
Secondary Outcome Measure Information:
Title
Assess acute procedural success (PVI)
Description
Acute procedural success is defined as successful electrical isolation of the pulmonary veins after the ablation procedure as assessed via a diagnostic catheter.
Time Frame
3 Month
Title
Assess quality of life: EQ-5D-5L
Description
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.
Time Frame
12 Month and 36 Month
Title
Evaluate post-procedural interventions for atrial arrhythmias
Description
Post-procedural interventions for atrial arrhythmias will be collected and reported.
Time Frame
12 Month and 36 Month
Title
Evaluate incidence rate of post-procedure events
Description
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.
Time Frame
12 Month and 36 Month
Title
Characterize AF burden seen on Reveal LINQ
Description
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.
Time Frame
12 Month and 36 Month
Title
Characterize AF burden data seen on Reveal LINQ in subjects with any post-procedural intervention for AF
Description
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.
Time Frame
12 Month and 36 Month
Title
Comparison of the lesion area as measured by cardiac MRI at Month 3
Description
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.
Time Frame
3 Month
Title
Evaluate the relation between outcome and AF burden in the 4 weeks before ablation (Reveal LINQ will be assessed)
Description
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
Time Frame
3 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, Prof. Dr.
Organizational Affiliation
Asklepios St. Georg, Hamburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Pasteur Toulouse
City
Toulouse
State/Province
Cedex 3
ZIP/Postal Code
31076
Country
France
Facility Name
Herz-Zentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Facility Name
Cardioangiologisches Centrum Bethanien CCB
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Asklepios St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein / Campus Lübeck
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
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FIRE AND ICE II Trial Pilot
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