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 January 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: January 24, 2014
Last verified: January 2014

December 6, 2011
January 24, 2014
December 2011
August 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01490814 on ClinicalTrials.gov Archive Site
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;
Not Provided
Not Provided
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FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Symptomatic Paroxysmal Atrial Fibrillation (PAF)
  • 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.
  • 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.
  • Active Comparator: Cryoballoon ablation
    Intervention: Procedure: Electrical isolation of the pulmonary veins
  • Active Comparator: Radiofrequency ablation
    Intervention: Procedure: Electrical isolation of pulmonary veins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
572
October 2015
August 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years to 75 Years
No
Contact: Ralf Meyer, Dr. +49 1755810431 ralf.meyer@medtronic.com
Czech Republic,   France,   Germany,   Hungary,   Italy,   Netherlands,   Spain,   Switzerland
 
NCT01490814
FI-123
Yes
Medtronic International Trading Sarl
Medtronic International Trading Sarl
Medtronic
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. Asklepios Klinikum St. Georg
Medtronic International Trading Sarl
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP