Persistent Atrial FibrillationNCT03706677
FIRE AND ICE II Trial Pilot
A study testing Cryoballoon (Arctic Front Advance Cryoballoon) and Radiofrequency Catheter (ThermoCool Smarttouch) in people with Persistent Atrial Fibrillation and Atrial Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in 2 countries.
Trial 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®… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Atrial Arrhythmia
- What is being tested?
- Cryoballoon (Arctic Front Advance Cryoballoon) and Radiofrequency Catheter (ThermoCool Smarttouch)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 5 Apr 2019to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Herz-Zentrum Bad Krozingen
Bad Krozingen, 79189
Cardioangiologisches Centrum Bethanien CCB
Frankfurt am Main, 60431
Asklepios St. Georg
Hamburg, 20099
Universitätsklinikum Schleswig-Holstein / Campus Lübeck
Lübeck, 23538
About this study
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).
Read the 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.
- Conditions
- Persistent Atrial Fibrillation, Atrial Arrhythmia
- Being tested
- Cryoballoon (Arctic Front Advance Cryoballoon), Radiofrequency Catheter (ThermoCool Smarttouch)
- Keywords
- Ablation, Cryoballoon, Radiofrequency
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryoballoon (Arctic Front Advance Cryoballoon)Device
Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)
Radiofrequency Catheter (ThermoCool Smarttouch)Device
Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)
| Study group | Role | What they receive |
|---|---|---|
| CRYO group | Active comparator | 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) Receives: Device: Cryoballoon (Arctic Front Advance Cryoballoon) |
| RF group | Active comparator | 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) Receives: Device: Radiofrequency Catheter (ThermoCool Smarttouch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Month
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.
Measured: 12 Month
Secondary outcomes (8)
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.
Measured: 3 Month
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.
Measured: 12 Month and 36 Month
Evaluate post-procedural interventions for atrial arrhythmias
Post-procedural interventions for atrial arrhythmias will be collected and reported.
Measured: 12 Month and 36 Month
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.
Measured: 12 Month and 36 Month
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.
Measured: 12 Month and 36 Month
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.
Measured: 12 Month and 36 Month
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.
Measured: 3 Month
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
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start5 Apr 2019
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization 1:1 between Cryoballoon ablation and Radiofrequency ablation
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- genae associates (CRO), Antwerp, Belgium, King's College London, Deutsches Herzzentrum Muenchen
- Responsible party
- Sponsor
- Investigators
- Karl-Heinz Kuck, Prof. Dr., Principal investigator, Asklepios St. Georg, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706677
- Sponsor's protocol ID
- MDT17037
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2018
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIRE AND ICE II Trial Pilot
- ClinicalTrials.gov ID
- NCT03706677
- Acronym / sponsor ID
- MDT17037
- Conditions
- Persistent Atrial Fibrillation, Atrial Arrhythmia
- Keywords
- Ablation, Cryoballoon, Radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Collaborators
- genae associates (CRO), Antwerp, Belgium, King's College London, Deutsches Herzzentrum Muenchen
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization 1:1 between Cryoballoon ablation and Radiofrequency ablation
| Arm | Type | Receives |
|---|---|---|
| CRYO group | Active comparator | Device: 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 | Active comparator | Device: 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoballoon (Arctic Front Advance Cryoballoon)Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter) | Device | CRYO group |
| Radiofrequency Catheter (ThermoCool Smarttouch)Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter) | Device | RF group |
Primary outcome
Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure)
Time frame: 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))
Time frame: 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.
8 secondary outcomes
Assess acute procedural success (PVI)
Time frame: 3 Month
Assess quality of life: EQ-5D-5L
Time frame: 12 Month and 36 Month
Evaluate post-procedural interventions for atrial arrhythmias
Time frame: 12 Month and 36 Month
Evaluate incidence rate of post-procedure events
Time frame: 12 Month and 36 Month
Characterize AF burden seen on Reveal LINQ
Time frame: 12 Month and 36 Month
Characterize AF burden data seen on Reveal LINQ in subjects with any post-procedural intervention for AF
Time frame: 12 Month and 36 Month
Comparison of the lesion area as measured by cardiac MRI at Month 3
Time frame: 3 Month
Evaluate the relation between outcome and AF burden in the 4 weeks before ablation (Reveal LINQ will be assessed)
Time frame: 3 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl-Heinz Kuck, Prof. Dr. principal investigator
Asklepios St. Georg, Hamburg
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon (Arctic Front Advance Cryoballoon) and Radiofrequency Catheter (ThermoCool Smarttouch) in people with Persistent Atrial Fibrillation and Atrial Arrhythmia, run by Medtronic Cardiac Rhythm and Heart Failure at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Objective (not powered within pilot) (time to clinical treatment failure) (time frame: 12 Month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.