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

This study is not yet open for participant recruitment.
Verified October 2013 by Medtronic Bakken Research Center
Sponsor:
Collaborator:
Medtronic Atrial Fibrillation Solutions
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01803438
First received: March 1, 2013
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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).


Condition Intervention Phase
Symptomatic Paroxysmal Atrial Fibrillation Without Clinically Significant Heart Diseases
Device: cryoballoon ablation system
Drug: Antiarrhythmic Drugs
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Freedom from any atrial arrhythmia recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary endpoint is freedom from any atrial arrhythmia recurrence at 12 months (at least one episode of AF, atrial flutter or atrial tachycardia with a duration > 30 seconds documented by 7 day Holter ECG or any other printed ECG recording following a blanking period or a dosing optimizing period of 3 months).


Secondary Outcome Measures:
  • quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The quality of life of the two arms measured by means of SF-36 Health Survey and Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaires will be compared at 12 months follow-up.

  • Hospital or emergency services accesses [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Hospital or emergency services accesses due to symptoms caused by documented atrial arrhythmias will be compared in the two arms at 12 months follow-up.

  • Freedom from occurrence of AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from occurrence of AF (after 3 months blanking period) will be compared between the two arms at 12 months follow-up.

  • Freedom from occurrence of documented left atrial tachycardia and left atrial flutter [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from occurrence of documented left atrial tachycardia and typical - or atypical left atrial flutter (after 3 months blanking period or AAD optimization period) will be compared between the two arms at 12 months follow-up.

  • Symptomatic palpitations burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Symptomatic palpitations burden will be evaluated by mean of Patient's diary information and compared between the two arms at 12 months follow-up.

  • Severe adverse events incidence [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Severe adverse events incidence will be compared between the two arms during the whole course of the study.

  • Freedom from persistent AF [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Freedom from persistent AF (AF episode lasting longer than 7 days or interrupted by pharmacological or electrical cardioversion after 48h from the onset of the episode) will be compared between the two arms at 12 months follow-up.

  • Echocardiographic left atrial re-modelling [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Echocardiographic left atrial parameters will be compared between the two arms at 6 and 12 months follow ups.

  • health care utilization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency, type and associated cost of health care utilization and utility will be compared between the two arms at 12 months follow-up.


Estimated Enrollment: 218
Study Start Date: October 2013
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AADs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Drug: Antiarrhythmic Drugs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Experimental: Cryoablation procedure
electrical pulmonary veins isolation performed with cryoballoon ablation system
Device: cryoballoon ablation system

  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01803438

Contacts
Contact: Laura Manotta, MS +39 02 241371 laura.manotta@/medtronic.com

Locations
Belgium
Heart Rhythm Management Centre, UZ Brussels - VUB Brussel Not yet recruiting
Brussel, Belgium
France
CHU Amiens Not yet recruiting
Amiens, France
Germany
Kerckhoff - Klinik Not yet recruiting
Bad Nauheim, Germany
Sponsors and Collaborators
Medtronic Bakken Research Center
Medtronic Atrial Fibrillation Solutions
Investigators
Principal Investigator: Malte Kuniss, MD Kerckhoff - Klinik, Bad Nauheim, Germany
Principal Investigator: GianBattista Chierchia, MD Heart Rhythm Management Centre, UZ Brussels - VUB Brussel, Belgium
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01803438     History of Changes
Other Study ID Numbers: Cryo-FIRST
Study First Received: March 1, 2013
Last Updated: October 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:
paroxysmal Atrial Fibrillation
Cryoablation
Pulmonary Vein Isolation

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Diseases
Arrhythmias, Cardiac
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014