Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation

Brief Summary

Official Title: “Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.”

The purpose of this study is to evaluate the effectiveness of Pulmonary Vein Isolation (PVI) performed with the Arctic Front™ Advance Cardiac CryoAblation Catheter System as first-line therapy in comparison with antiarrhythmic drugs (AAD) in patients with paroxysmal atrial fibrillation (AF).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: June 2017

Interventions Used in this Clinical Trial

  • Device: cryoballoon ablation system
  • Drug: Antiarrhythmic Drugs
    • AAD therapy based on hospital clinical practice according to ESC Guidelines 2012

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: AADs
    • AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
  • Experimental: Cryoablation procedure
    • electrical pulmonary veins isolation performed with cryoballoon ablation system

Outcome Measures for this Clinical Trial

Primary Measures

  • Freedom from any atrial arrhythmia recurrence
    • Time Frame: 12 months
      Safety Issue?: No

Secondary Measures

  • quality of life
    • Time Frame: 12 months
      Safety Issue?: No
  • Hospital or emergency services accesses
    • Time Frame: 12 Months
      Safety Issue?: No
  • Freedom from occurrence of AF
    • Time Frame: 12 months
      Safety Issue?: No
  • Freedom from occurrence of documented left atrial tachycardia and left atrial flutter
    • Time Frame: 12 months
      Safety Issue?: No
  • Symptomatic palpitations burden
    • Time Frame: 12 months
      Safety Issue?: No
  • Severe adverse events incidence
    • Time Frame: 12 months
      Safety Issue?: Yes
  • Freedom from persistent AF
    • Time Frame: 12 months
      Safety Issue?: No
  • Echocardiographic left atrial re-modelling
    • Time Frame: 12 months
      Safety Issue?: No
  • health care utilization
    • Time Frame: 12 months
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

  • Subject has been diagnosed with symptomatic paroxysmal atrial fibrillation as defined above with a history of at least three months of known AF and at least two symptomatic episodes in the last three months prior to inclusion.
  • At least one episode of AF must be documented during the prior year by any kind of ECG recording.
  • Subject has structural normal heart with an LVEF ≥ 50%, thickness of the inter-ventricular septum <11 mm and left atrium diameters (short axis) < 46 mm obtained by transthoracic echocardiography.
  • Subject has normal ECG parameters (QRS width in the 12 channel surface ECG ≤110 ms, QTc – interval < 440 ms, PQ – interval ≤ 210 ms; all parameters should be measured at sinus rhythm).
  • Subject is at least 18 and ≤75 years of age old.
  • Subject is able and willing to give informed consent

Exclusion Criteria

  • Subject developed persistent AF at least once in history (electrical or pharmacological cardioversion after 48h or episode duration >7 days).
  • Subject has documented typical atrial flutter.
  • Subject has any history of successful or unsuccessful treatment of AF with class I or III antiarrhythmic or sotalol with a sufficient dose and time of application according to current guidelines.
  • Subject had any previous left atrial ablation.
  • Subject had any previous cardiac surgery, e.g. prosthetic valves.
  • Subject has permanent pacemaker or defibrillator implant.
  • Subject has 2° type II, 3° degree AV-block or left/right bundle branch block pattern
  • Subject has unstable angina pectoris.
  • Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
  • Subject has symptomatic carotid stenosis.
  • Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension or any other evidence of significant lung disease.
  • Subject has any contraindication for oral anticoagulation.
  • Subject has any history of previous transient ischemic attack or stroke.
  • Subject has known intra-cardiac thrombus formation.
  • Subject has any significant congenital heart defect corrected or not (except for patent foramen ovale that is allowed).
  • Subject has evidence of congestive heart failure (NYHA class II, III or IV) in sinus rhythm.
  • Subject has hypertrophic cardiomyopathy.
  • Subject has abnormal long or short QT interval, signs of Brugada syndrome, known inheriting ion channel disease on the family, arrhythmogenic right ventricular dysplasia.
  • Subject has sarcoidosis.
  • Subject has pulmonary vein stent.
  • Subject has myxoma. Exclusion criteria based on laboratory abnormalities
  • Subject has thrombocytosis (platelet count > 600,000 / μl) or thrombocytopenia (platelet count <100,000 / μl).
  • Subject has any untreated or uncontrolled hyperthyroidism or hypothyroidism.
  • Subject has renal dysfunction with glomerular filtration rate < 80 ml / min.
  • Subject has known cryoglobulinaemia. General exclusion criteria
  • Subject has a reversible causes for AF like hyperthyroidism and alcoholism.
  • Subject is a pregnant woman or woman of childbearing potential not on adequate birth control: only woman with a highly effective method of contraception [oral contraception or intra-uterine device] (who must have a negative pregnancy test within 1 week of randomization) or sterile woman can be enrolled.
  • Subject is a breastfeeding woman.
  • Subject has an active systemic infection.
  • Subject is employed by Medtronic or by the department of any of the investigators or is a close relative of any of the investigators.
  • Subject is unwilling or unable to comply fully with study procedures and follow-up due to any disease condition, which can raise doubt about compliance and influencing the study outcome especially any kind of cancer, severe bleeding in history or a suspected pro-coagulant state.
  • Legal incapacity or evidence that a subject cannot understand the purpose and risks of the study or inability to comply fully with study procedures and follow up.
  • Subject has a life expectancy of ≤ 1 year.
  • Subject is participating in any other clinical study.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Medtronic Bakken Research Center
  • Collaborator
    • Medtronic Atrial Fibrillation Solutions
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Malte Kuniss, MD, Principal Investigator, Kerckhoff – Klinik, Bad Nauheim, Germany
    • GianBattista Chierchia, MD, Principal Investigator, Heart Rhythm Management Centre, UZ Brussels – VUB Brussel, Belgium
  • Overall Contact(s)
    • Laura Manotta, MS, +39 02 241371, laura.manotta@|


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