Catheter Cryoablation Versus Antiarrhythmic Drug as First-Line Therapy of Paroxysmal Atrial Fibrillation
NCT ID: NCT01803438
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
220 participants
INTERVENTIONAL
2014-06-30
2020-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AADs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Antiarrhythmic Drugs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Cryoablation procedure
electrical pulmonary veins isolation performed with cryoballoon ablation system
cryoballoon ablation system
Interventions
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cryoballoon ablation system
Antiarrhythmic Drugs
AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
Eligibility Criteria
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Inclusion Criteria
* 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 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 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Malte Kuniss, MD
Role: PRINCIPAL_INVESTIGATOR
Kerckhoff - Klinik, Bad Nauheim, Germany
GianBattista Chierchia, MD
Role: PRINCIPAL_INVESTIGATOR
Heart Rhythm Management Centre, UZ Brussels - VUB Brussel, Belgium
Locations
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nstituto Cardiovascular de Buenos Aires
Buenos Aires, , Argentina
Monash Medical Centre
Melbourne, , Australia
Heart Rhythm Management Centre, UZ Brussels - VUB Brussel
Brussels, , Belgium
Klinicki bolnicki centar Sestre Milosrdnice
Zagreb, , Croatia
Klinicki bolnicki centar Sestre
Zagreb, , Croatia
NCHU Amiens
Amiens, , France
CHU Grenoble
Grenoble, , France
CHU La Pitié
Paris, , France
CHU Charles Nicolle
Rouen, , France
Kerckhoff - Klinik
Bad Nauheim, , Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Universitätsklinikum Eppendorf
Hamburg, , Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, , Germany
Klinikum Bogenhausen
Munich, , Germany
Maria Cecilia Hospital
Cotignola, , Italy
Ospedale S.S. Giacomo e Cristoforo
Massa, , Italy
Catharina Ziekenhuis
Eindhoven, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haukeland Hospital
Bergen, , Norway
Countries
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References
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Andrade JG, Moss JWE, Kuniss M, Sadri H, Wazni O, Sale A, Ismyrloglou E, Chierchia GB, Kaplon R, Mealing S, Bainbridge J, Bromilow T, Lane E, Khaykin Y. The Cost-Effectiveness of First-Line Cryoablation vs First-Line Antiarrhythmic Drugs in Canadian Patients With Paroxysmal Atrial Fibrillation. Can J Cardiol. 2024 Apr;40(4):576-584. doi: 10.1016/j.cjca.2023.11.019. Epub 2023 Nov 23.
Pavlovic N, Chierchia GB, Velagic V, Hermida JS, Healey S, Arena G, Badenco N, Meyer C, Chen J, Iacopino S, Anselme F, Dekker L, Scazzuso F, Packer DL, de Asmundis C, Pitschner HF, Piazza FD, Kaplon RE, Kuniss M; Cryo-FIRST Investigators. Initial rhythm control with cryoballoon ablation vs drug therapy: Impact on quality of life and symptoms. Am Heart J. 2021 Dec;242:103-114. doi: 10.1016/j.ahj.2021.08.007. Epub 2021 Sep 8.
Other Identifiers
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Cryo-FIRST
Identifier Type: -
Identifier Source: org_study_id
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