FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation (NCT01490814) | Clinical Trial Compass
CompletedNot Applicable
FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation
Czechia, France769 participantsStarted 2011-12
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Cryoglo…
What they're measuring
1
Number of Subjects With Recurrence of Atrial Arrhythmias or Prescription of Anti-arrhythmic Drug or Re-ablation After a Blanking Period of Three Months After the Initial Ablation Procedure
Timeframe: 33 months
2
Number of Subjects With a Primary Safety Event. A Primary Safety Event Includes a Composite of Death (Including Cardiovascular Death), All-cause Stroke/Transient Ischemic Attack (TIA) and Serious Adverse Events of Special Interest.