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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 4, 2014
Last verified: June 2014
  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: June 2014
Estimated Primary Completion Date: June 2017 (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
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: 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
Clinique Saint Gatien Recruiting
Tours, France, 37000
Contact: Olivier Cesari, MD         
Contact: Christophe Loose, MD         
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: June 4, 2014
Health Authority: France: ANSM
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 July 24, 2014