- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803438
Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
February 24, 2020 updated by: Medtronic Cardiac Rhythm and Heart Failure
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 Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
220
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires, Argentina, C1428
- nstituto Cardiovascular de Buenos Aires
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Melbourne, Australia
- Monash Medical Centre
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Brussel, Belgium
- Heart Rhythm Management Centre, UZ Brussels - VUB Brussel
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Zagreb, Croatia
- Klinički bolnički centar Sestre Milosrdnice
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Zagreb, Croatia
- Klinicki bolnicki centar Sestre
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Amiens, France
- NCHU Amiens
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Grenoble, France
- CHU Grenoble
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Paris, France
- CHU La Pitié
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Rouen, France
- CHU Charles Nicolle
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Bad Nauheim, Germany
- Kerckhoff - Klinik
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Frankfurt, Germany, 60431
- Cardioangiologisches Centrum Bethanien
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Hamburg, Germany, 20246
- Universitätsklinikum Eppendorf
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Kaiserslautern, Germany, 67655
- Westpfalz-Klinikum GmbH
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Munich, Germany
- Klinikum Bogenhausen
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Cotignola, Italy, 48033
- Maria Cecilia Hospital
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Massa, Italy
- Ospedale S.S. Giacomo e Cristoforo
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Eindhoven, Netherlands, 5623 EJ
- Catharina Ziekenhuis
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Rotterdam, Netherlands
- Erasmus MC
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Bergen, Norway
- Haukeland Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject has been diagnosed with symptomatic paroxysmal atrial fibrillation as defined above and at least two symptomatic episodes in the last six 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 ≤12 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 ≤120 ms, QTc - interval < 440 ms, PQ - interval ≤ 210 ms; all parameters should be measured at sinus rhythm).
- Subject is at least 18 and not older than 75years 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 the intention to prevent an AF recurrence. Patients pretreated with above AAD at maximum 48 hours with the intention to convert an AF episode are allowed.
- 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 < 60 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 the start of the therapy) 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 currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: AADs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
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AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
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Experimental: Cryoablation procedure
electrical pulmonary veins isolation performed with cryoballoon ablation system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Freedom from any atrial arrhythmia recurrence
Time Frame: 12 months
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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).
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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quality of life
Time Frame: 12 months
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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.
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12 months
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Hospital or emergency services accesses
Time Frame: 12 Months
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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.
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12 Months
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Freedom from occurrence of AF
Time Frame: 12 months
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Freedom from occurrence of AF (after 3 months blanking period) will be compared between the two arms at 12 months follow-up.
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12 months
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Freedom from occurrence of documented left atrial tachycardia and left atrial flutter
Time Frame: 12 months
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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.
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12 months
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Symptomatic palpitations burden
Time Frame: 12 months
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Symptomatic palpitations burden will be evaluated by mean of Patient's diary information and compared between the two arms at 12 months follow-up.
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12 months
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Severe adverse events incidence
Time Frame: 12 months
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Severe adverse events incidence will be compared between the two arms during the whole course of the study.
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12 months
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Freedom from persistent AF
Time Frame: 12 months
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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.
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12 months
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Echocardiographic left atrial re-modelling
Time Frame: 12 months
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Echocardiographic left atrial parameters will be compared between the two arms at 6 and 12 months follow ups.
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12 months
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health care utilization
Time Frame: 12 months
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Frequency, type and associated cost of health care utilization and utility will be compared between the two arms at 12 months follow-up.
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
October 16, 2019
Study Completion (Actual)
January 20, 2020
Study Registration Dates
First Submitted
March 1, 2013
First Submitted That Met QC Criteria
March 1, 2013
First Posted (Estimate)
March 4, 2013
Study Record Updates
Last Update Posted (Actual)
February 25, 2020
Last Update Submitted That Met QC Criteria
February 24, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cryo-FIRST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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