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FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Medtronic International Trading Sarl
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic International Trading Sarl
ClinicalTrials.gov Identifier:
NCT01490814
First received: December 6, 2011
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

Comparing efficacy and safety of isolation of the pulmonary veins (PV) using a Cryoballoon catheter versus a radiofrequency ablation with a ThermoCool catheter in patients with paroxysmal atrial fibrillation.


Condition Intervention
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Procedure: Electrical isolation of the pulmonary veins
Procedure: Electrical isolation of pulmonary veins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Controlled, Prospective, Non-Inferiority, Parallel-Group, Randomised, Interventional, Open, Blinded Outcome Assessment (PROBE-Design), Multi-centre Trial, Comparing Efficacy and Safety of Isolation of the Pulmonary Veins With a Cryoballoon Catheter Versus a Radiofrequency Ablation With a ThermoCool Catheter in Patients With Paroxysmal Atrial Fibrillation

Resource links provided by NLM:


Further study details as provided by Medtronic International Trading Sarl:

Primary Outcome Measures:
  • Time to first documented recurrence of atrial arrhythmias (a blanking period of three months will be maintained after the initial procedure). [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to the first occurrence of each of the components of the primary outcome [ Designated as safety issue: No ]
    The secondary outcome parameters are defined as all-cause death; Arrhythmia-related death; total procedural duration; total time of fluoroscopy; time to the first occurrence of each of the components of the primary outcome; time to recurrent atrial fibrillation (AF); time to first cardiovascular hospitalization; number of cardiovascular hospitalizations (over-night stays); quality of life changes at 12 months compared to baseline; time to first symptomatic AF recurrence;


Estimated Enrollment: 768
Study Start Date: December 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cryoballoon ablation Procedure: 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.
Active Comparator: Radiofrequency ablation Procedure: 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.

Detailed Description:

The purpose of this randomized clinical trial is to compare the efficacy and safety of isolating the PVs with either the cryoballoon or a RF ablation technique with a ThermoCool catheter, a system which can be regarded as standard for ablation. In total 572 patients with paroxysmal atrial fibrillation will be randomized for either radiofrequency (RF) or cryoballoon. With both techniques, PV isolation will be performed. Primary end point of the trial is the time to first recurrence of atrial arrhythmias or prescription of anti-arrhythmic drugs after a blanking period of three months. Treatment success will be evaluated by using weekly electrocardiography (ECG) monitoring (transtelephonic transmission/Tele-ECG) and using Holter electrocardiograms.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic PAF with at least two episodes and at least one episode documented (30 seconds episode length, documented by ECG within last 12 months).
  • 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:

General exclusion criteria

  • Any disease that limits life expectancy to less than one year.
  • 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.

Exclusion criteria related to a cardiac condition

  • 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.

Exclusion criteria based on laboratory abnormalities

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490814

Contacts
Contact: Ralf Meyer, Dr. +49 1755810431 ralf.meyer@medtronic.com

Locations
Czech Republic
Na Homolce Hospital, Cardiology Recruiting
Prague, Czech Republic, 515030
Contact: Petr Neuzil, Dr.    +420 257272211    petr.neuzil@homolka.cz   
Principal Investigator: Petr Neuzil, Dr.         
Sub-Investigator: Jan Skoda, Dr.         
Sub-Investigator: Jan Petru, Dr.         
Sub-Investigator: Lucie Sedivá, Dr.         
France
Hospital Henri Mondor CHU, Service de Cardiologie Not yet recruiting
Créteil, France, 94010
Contact: Nicolas Lellouche, Dr.    +33 149 812257    nicolas.lellouche@hmn.aphp.fr   
Principal Investigator: Nicolas Lellouche, Dr.         
CHU Lyon, Départment de Rythmologie, Hospital Cardiologique Pradel Not yet recruiting
Lyon, France, 69677
Contact: Philippe Chevalier, Prof. Dr.       philippe.chevalier@chu-lyon.fr   
Principal Investigator: Philippe Chevalier, Prof. Dr.         
Centre Chirurgical Ambroise Paré Not yet recruiting
Neuilly Sur Seine, France, 92200
Contact: Olivier Thomas, Dr.       olivier.thomas@free.fr   
Principal Investigator: Olivier Thomas, Dr.         
La Clinique Pasteur, 45 Avenue de Lombez Recruiting
Toulouse, France, 31076
Contact: Jean-Paul Albenque, Dr.    +33 0562211645    j.albenque@clinique-pasteur.com   
Principal Investigator: Jean-Paul Albenque, Dr.         
Sub-Investigator: Serge Boveda, Dr.         
Sub-Investigator: Nicoles Combes, Dr.         
Sub-Investigator: Stéphane Combes, Dr.         
Germany
Herz-Zentrum Bad Krozingen Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Arentz, Prof. Dr.    +49 7633 402 2422    thomas.arentz@herzzentrum.de   
Principal Investigator: Thomas Arentz, Prof. Dr.         
Sub-Investigator: Jochen Schiebeling-Römer, Dr.         
Sub-Investigator: Klaus Astheimer, Dr.         
Sub-Investigator: Amir Jadidi, Dr.         
Klinik für Kardiologie II mit interventioneller Elektrophysiologie Recruiting
Bad Neustadt/Saale, Germany, 97616
Contact: Thomas Deneke, PD Dr.    +49 09771 665111    thomas.deneke@kardiologie-bad-neustadt.de   
Principal Investigator: Thomas Deneke, PD Dr.         
Sub-Investigator: Anja Schade, Dr.         
Sub-Investigator: Joachim Krug, Dr.         
Cardioangiologisches Centrum Bethanien - CCB Recruiting
Frankfurt, Germany, 60431
Contact: Julian Chun, Dr.    +49 69 945028 110    j.chun@ccb.de   
Principal Investigator: KR Julian Chun, Dr.         
Sub-Investigator: Boris Schmidt, Dr.         
Sub-Investigator: Mehmet Kulikoglu, Dr.         
Sub-Investigator: Verena Urban, Dr.         
Sub-Investigator: Alexander Fürnkranz, Dr.         
Universitätsklinikum Greifswald Elektrophysiologie Recruiting
Greifswald, Germany, 17475
Contact: Mathias Busch, Dr.    +49 3834 86 - 0    buschm@uni-greifswald.de   
Principal Investigator: Mathias Busch, Dr.         
Asklepios Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, Prof. Dr.    +49 40 181885-2468    k.kuck@asklepios.com   
Sub-Investigator: Feifan Ouyang, Dr.         
Sub-Investigator: Erik Wißner, Dr.         
Sub-Investigator: Andreas Metzner, Dr.         
Herz-Zentrum-Bodensee Konstanz Recruiting
Konstanz, Germany, 78464
Contact: Volker Kühlkamp, Prof. Dr.    +49 7531 897 0    volker.kuehlkamp@herz-zentrum.com   
Principal Investigator: Volker Kühlkamp, Prof. Dr.         
Sub-Investigator: Bernd Eigenberger, Dr.         
Sub-Investigator: Holger Stöckel, Dr.         
Hungary
Semmelweis University of Medicine, Kardiovaskuläres Zentrum Recruiting
Budapest, Hungary, 1122
Contact: Laszlo Géller, Dr.    +36-1 458-6840    laszlo.geller@gmail.com   
Principal Investigator: Laszlo Géller, Dr.         
Sub-Investigator: Tamás Tahin, Dr.         
Sub-Investigator: Gábor Széplaki, Dr.         
Sub-Investigator: Katalin Solymossy, Dr.         
Italy
Cardiac Arrhythmia Research Centre Department of Cardiovascular Medicine Centro Cardiologico Monzino University of Milan Recruiting
Milan, Italy, 20138
Contact: Claudio Tondo, Prof. Dr.    +39 258002340    claudio.tondo@ccfm.it   
Principal Investigator: Claudio Tondo, Prof. Dr.         
Sub-Investigator: Gaetano Fassini, Dr.         
Sub-Investigator: Osama Al-Nono, Dr.         
Netherlands
Isala Klinieken loc. Weezenlanden Diagram Clinical Resarch Recruiting
Zwolle, Netherlands, 8011
Contact: Arif Elvan, Dr.    +31 38 424 5000    a.elvan@isala.nl   
Principal Investigator: Arif Elvan, Dr.         
Spain
Hospital Clinic, University of Barcelona Recruiting
Barcelona, Spain, 08036
Contact: Lluis Mont, Dr.    +34 93 2275551    lmont@clinic.ub.es   
Sub-Investigator: Josep Brugada, Prof. Dr.         
Principal Investigator: Lluis Mont, Dr.         
Sub-Investigator: Elena Arbelo, Dr.         
Sub-Investigator: Felipe Bisbal, Dr.         
Arrhythmia Unit Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Nicasio Pérez-Castellano, Dr.    +34 91 330 30 0 ext 7278    nperez.hcsc@salud.madrid.org   
Principal Investigator: Nicasio Pérez-Castellano, Dr.         
Sub-Investigator: Julián Pérez-Villacastin, Dr.         
Sub-Investigator: Javier Moreno-Planas, Dr.         
Hospital Universitario Virgen de la Victoria, Department of Cardiology, Campus Teatinos sn Recruiting
Malaga, Spain, 29010
Contact: Alberto Barrera, Dr.    +34 951 032 000    albarrera62@gmail.com   
Principal Investigator: Alberto Barrera, Dr.         
Sub-Investigator: Javier Alzueta, Dr.         
Hospital Clinico Universtitario, Cardiology Department Arrhythmia Unit Recruiting
Valencia, Spain, 46014
Contact: Ricardo Ruiz-Granell, Dr.    +34 963 862 600    rruizg@meditex.es   
Principal Investigator: Ricardo Ruiz-Granell, Dr.         
Switzerland
Universitätsspital Basel, Elektrophysiologie/ Kardiologie Recruiting
Basel, Switzerland, 4031
Contact: Michael Kühne, PD Dr.    +41 61 2652525    kuehnem@uhbs.ch   
Principal Investigator: Michael Kühne, PD Dr.         
Sponsors and Collaborators
Medtronic International Trading Sarl
Medtronic
Investigators
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. Asklepios Klinikum St. Georg
  More Information

Additional Information:
Publications:
Responsible Party: Medtronic International Trading Sarl
ClinicalTrials.gov Identifier: NCT01490814     History of Changes
Other Study ID Numbers: FI-123
Study First Received: December 6, 2011
Last Updated: September 23, 2014
Health Authority: Germany: Ethik-Kommission der Albert-Ludwigs-Universität Freiburg

Keywords provided by Medtronic International Trading Sarl:
PAF
two episodes within the last twelve months one episode documented
Documented treatment failure of at least one antiarrhythmic
drug AAD Type I or III including β-blocker and AAD intolerance

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014