FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
NCT ID: NCT01490814
Last Updated: 2018-11-02
Study Results
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View full resultsBasic Information
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COMPLETED
NA
769 participants
INTERVENTIONAL
2011-12-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cryoballoon ablation
Electrical isolation of the pulmonary veins
Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Radiofrequency ablation
Electrical isolation of pulmonary veins
Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Interventions
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Electrical isolation of the pulmonary veins
Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Electrical isolation of pulmonary veins
Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
Eligibility Criteria
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Inclusion Criteria
* Documented treatment failure for effectiveness of at least one anti-arrhythmic drug(AAD Type I or III, including β-blocker and AAD intolerance).
* ≥ 18 and ≤ 75 years of age.
* Patients who are mentally and linguistically able to understand the aim of the trial and to show sufficient compliance in following the trial protocol.
* Patient is able to verbally acknowledge and understand the associated risks, benefits, and treatment alternatives to therapeutic options of this trial: cryoballoon ablation system or standard RF ablation technique. The patients, by providing informed consent, agree to these risks and benefits as stated in the patient informed consent document. All the details have been presented to him and he has signed the informed consent form for the trial.
Exclusion Criteria
* Participation in another clinical trial (of a drug, device or biologic), either within the past two months or ongoing.
* Pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception \[oral contraception or intrauterine device (IUD)\] or sterile women can be randomized.
* Breastfeeding women.
* Substance misuse.
* Active systemic infection.
* Cryoglobulinaemia.
* Previous participation in this clinical trial.
* Employment by the sponsor or by the department of any of the investigators.
* Close relatives of any of the investigators.
* Patients with prosthetic valves.
* Any previous LA ablation or surgery.
* Any cardiac surgery or percutaneous coronary intervention (PCI) within three months prior to enrollment.
* Unstable angina pectoris.
* Myocardial infarction within three months prior to enrollment.
* Symptomatic carotid stenosis.
* Chronic obstructive pulmonary disease with detected pulmonary hypertension.
* Any condition contraindicating chronic anticoagulation.
* Stroke or transient ischemic attack within six months prior to enrollment.
* Any significant congenital heart defect corrected or not (including atrial septal defects or PV abnormalities) but not including patent foramen ovale.
* New York Heart Association (NYHA) class III or IV congestive heart failure.
* EF \< 35 % (determined by echocardiography within 60 days of enrollment as documented in patient medical history).
* Anteroposterior LA diameter \> 55 mm (by trans-thoracic echocardiography (TTE or TEE) within three months to prior enrollment).
* LA thrombus (TEE diagnostic performed on admission).
* Intracardiac thrombus.
* PV diameter \> 26 mm in right sided PVs.
* Mitral prosthesis.
* Hypertrophic cardiomyopathy (see Appendix IX)
* 2° (Type II) or 3° atrioventricular block.
* Brugada syndrome or long QT syndrome.
* Arrhythmogenic right ventricular dysplasia.
* Sarcoidosis.
* PV stent.
* Myxoma.
* Thrombocytosis (platelet count \> 600,000 / µl), thrombocytopenia (platelet count \< 100,000 / µl).
* Any untreated or uncontrolled hyperthyroidism or hypothyroidism.
* Severe renal dysfunction (stage V, requiring or almost requiring dialysis, glomerular filtration rate (GFR) \< 15 ml / min).
18 Years
75 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic Atrial Fibrillation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Karl-Heinz Kuck, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Asklepios Klinikum St. Georg
Locations
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Na Homolce Hospital, Cardiology
Prague, , Czechia
Hospital Henri Mondor CHU, Service de Cardiologie
Créteil, , France
CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel
Lyon, , France
Centre Chirurgical Ambroise Paré
Neuilly-sur-Seine, , France
La Clinique Pasteur, 45 Avenue de Lombez
Toulouse, , France
Herz-Zentrum Bad Krozingen
Bad Krozingen, , Germany
Klinik für Kardiologie II mit interventioneller Elektrophysiologie
Bad Neustadt/Saale, , Germany
Cardioangiologisches Centrum Bethanien - CCB
Frankfurt, , Germany
Universitätsklinikum Greifswald Elektrophysiologie
Greifswald, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Herz-Zentrum-Bodensee Konstanz
Konstanz, , Germany
Semmelweis University of Medicine, Kardiovaskuläres Zentrum
Budapest, , Hungary
Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan
Milan, , Italy
Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch
Zwolle, , Netherlands
Hospital Clinic, University of Barcelona
Barcelona, , Spain
Arrhythmia Unit Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn
Málaga, , Spain
Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit
Valencia, , Spain
Universitätsspital Basel, Elektrophysiologie/ Kardiologie
Basel, , Switzerland
Countries
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References
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Furnkranz A, Brugada J, Albenque JP, Tondo C, Bestehorn K, Wegscheider K, Ouyang F, Kuck KH. Rationale and Design of FIRE AND ICE: A multicenter randomized trial comparing efficacy and safety of pulmonary vein isolation using a cryoballoon versus radiofrequency ablation with 3D-reconstruction. J Cardiovasc Electrophysiol. 2014 Dec;25(12):1314-20. doi: 10.1111/jce.12529. Epub 2014 Nov 12.
Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.
Huang C, Wang J, He C, Yang K, Zhao H, Chen J, Su L. The Efficacy and Safety of Cryoballoon Versus Radiofrequency Ablation for the Treatment of Atrial Fibrillation: A Meta-Analysis of 15 International Randomized Trials. Cardiol Rev. 2024 Nov-Dec 01;32(6):546-553. doi: 10.1097/CRD.0000000000000531. Epub 2024 Oct 4.
Kuck KH, Brugada J, Furnkranz A, Chun KRJ, Metzner A, Ouyang F, Schluter M, Elvan A, Braegelmann KM, Kueffer FJ, Arentz T, Albenque JP, Kuhne M, Sticherling C, Tondo C; FIRE AND ICE Investigators. Impact of Female Sex on Clinical Outcomes in the FIRE AND ICE Trial of Catheter Ablation for Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2018 May;11(5):e006204. doi: 10.1161/CIRCEP.118.006204.
Chun KRJ, Brugada J, Elvan A, Geller L, Busch M, Barrera A, Schilling RJ, Reynolds MR, Hokanson RB, Holbrook R, Brown B, Schluter M, Kuck KH; FIRE AND ICE Investigators. The Impact of Cryoballoon Versus Radiofrequency Ablation for Paroxysmal Atrial Fibrillation on Healthcare Utilization and Costs: An Economic Analysis From the FIRE AND ICE Trial. J Am Heart Assoc. 2017 Jul 27;6(8):e006043. doi: 10.1161/JAHA.117.006043.
Kuck KH, Furnkranz A, Chun KR, Metzner A, Ouyang F, Schluter M, Elvan A, Lim HW, Kueffer FJ, Arentz T, Albenque JP, Tondo C, Kuhne M, Sticherling C, Brugada J; FIRE AND ICE Investigators. Cryoballoon or radiofrequency ablation for symptomatic paroxysmal atrial fibrillation: reintervention, rehospitalization, and quality-of-life outcomes in the FIRE AND ICE trial. Eur Heart J. 2016 Oct 7;37(38):2858-2865. doi: 10.1093/eurheartj/ehw285. Epub 2016 Jul 5.
Luik A, Radzewitz A, Kieser M, Walter M, Bramlage P, Hormann P, Schmidt K, Horn N, Brinkmeier-Theofanopoulou M, Kunzmann K, Riexinger T, Schymik G, Merkel M, Schmitt C. Cryoballoon Versus Open Irrigated Radiofrequency Ablation in Patients With Paroxysmal Atrial Fibrillation: The Prospective, Randomized, Controlled, Noninferiority FreezeAF Study. Circulation. 2015 Oct 6;132(14):1311-9. doi: 10.1161/CIRCULATIONAHA.115.016871. Epub 2015 Aug 17.
Related Links
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Rationale and Design of FIRE AND ICE: A Multicenter Randomized Trial Comparing Efficacy and Safety of Pulmonary Vein Isolation using a Cryoballoon Versus Radiofrequency Ablation with 3D-reconstruction.
Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation.
FIRE AND ICE: LBCT ACC
Other Identifiers
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FI-123
Identifier Type: -
Identifier Source: org_study_id
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