Norwegian Study of Persistent Atrial Fibrillation Treatment: Cryoballoon Versus Radiofrequency Catheter Ablation
NCT ID: NCT03008811
Last Updated: 2021-11-12
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
NA
101 participants
INTERVENTIONAL
2016-11-30
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cryoballoon
Pulmonary vein isolation with cryoballoon catheter.
Pulmonary vein isolation with cryoballoon catheter.
Device: Arctic Front Advance™ cardiac cryoablation catheter system.
Radiofrequency
Pulmonary vein isolation with radiofrequency ablation catheter.
Pulmonary vein isolation with radiofrequency ablation.
Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
Interventions
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Pulmonary vein isolation with cryoballoon catheter.
Device: Arctic Front Advance™ cardiac cryoablation catheter system.
Pulmonary vein isolation with radiofrequency ablation.
Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
Eligibility Criteria
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Inclusion Criteria
* Subject is at least 18 and ≤ 75 years old.
* Subject is able and willing to give informed consent.
Exclusion Criteria
* Subject has any previous left atrial ablation procedure or surgery, including pulmonary vein isolation.
* Subject has presence of an intracavitary thrombus.
* Subject has uncontrolled heart failure.
* Subject has severe valvular disease.
* Subject has the left atrial diameter \> 60 mm confirmed by echocardiography.
* Subject has contraindications to systemic anticoagulation with heparin or oral anticoagulants.
* Subject has known cryoglobulinaemia.
* Subject has severe renal dysfunction.
* Subject who is or may potentially be pregnant.
* Subject has unstable angina pectoris.
* Subject has history of previous myocardial infarction or percutaneous intervention during the last three months.
* Subject has chronic obstructive pulmonary disease with detected pulmonary hypertension.
18 Years
75 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
University Hospital of North Norway
OTHER
Haukeland University Hospital
OTHER
Responsible Party
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Locations
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Haukeland University Hospital
Bergen, , Norway
University Hospital of North Norway
Tromsø, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
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References
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Biblo LA, Yuan Z, Quan KJ, Mackall JA, Rimm AA. Risk of stroke in patients with atrial flutter. Am J Cardiol. 2001 Feb 1;87(3):346-9, A9. doi: 10.1016/s0002-9149(00)01374-6.
Vidaillet H, Granada JF, Chyou Po, Maassen K, Ortiz M, Pulido JN, Sharma P, Smith PN, Hayes J. A population-based study of mortality among patients with atrial fibrillation or flutter. Am J Med. 2002 Oct 1;113(5):365-70. doi: 10.1016/s0002-9343(02)01253-6.
Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
Wolf PA, Mitchell JB, Baker CS, Kannel WB, D'Agostino RB. Impact of atrial fibrillation on mortality, stroke, and medical costs. Arch Intern Med. 1998 Feb 9;158(3):229-34. doi: 10.1001/archinte.158.3.229.
Corley SD, Epstein AE, DiMarco JP, Domanski MJ, Geller N, Greene HL, Josephson RA, Kellen JC, Klein RC, Krahn AD, Mickel M, Mitchell LB, Nelson JD, Rosenberg Y, Schron E, Shemanski L, Waldo AL, Wyse DG; AFFIRM Investigators. Relationships between sinus rhythm, treatment, and survival in the Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) Study. Circulation. 2004 Mar 30;109(12):1509-13. doi: 10.1161/01.CIR.0000121736.16643.11. Epub 2004 Mar 8.
Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.
Verma A, Marrouche NF, Natale A. Pulmonary vein antrum isolation: intracardiac echocardiography-guided technique. J Cardiovasc Electrophysiol. 2004 Nov;15(11):1335-40. doi: 10.1046/j.1540-8167.2004.04428.x.
Oral H, Scharf C, Chugh A, Hall B, Cheung P, Good E, Veerareddy S, Pelosi F Jr, Morady F. Catheter ablation for paroxysmal atrial fibrillation: segmental pulmonary vein ostial ablation versus left atrial ablation. Circulation. 2003 Nov 11;108(19):2355-60. doi: 10.1161/01.CIR.0000095796.45180.88. Epub 2003 Oct 13.
Saad EB, Rossillo A, Saad CP, Martin DO, Bhargava M, Erciyes D, Bash D, Williams-Andrews M, Beheiry S, Marrouche NF, Adams J, Pisano E, Fanelli R, Potenza D, Raviele A, Bonso A, Themistoclakis S, Brachmann J, Saliba WI, Schweikert RA, Natale A. Pulmonary vein stenosis after radiofrequency ablation of atrial fibrillation: functional characterization, evolution, and influence of the ablation strategy. Circulation. 2003 Dec 23;108(25):3102-7. doi: 10.1161/01.CIR.0000104569.96907.7F. Epub 2003 Nov 17.
Pappone C, Rosanio S, Augello G, Gallus G, Vicedomini G, Mazzone P, Gulletta S, Gugliotta F, Pappone A, Santinelli V, Tortoriello V, Sala S, Zangrillo A, Crescenzi G, Benussi S, Alfieri O. Mortality, morbidity, and quality of life after circumferential pulmonary vein ablation for atrial fibrillation: outcomes from a controlled nonrandomized long-term study. J Am Coll Cardiol. 2003 Jul 16;42(2):185-97. doi: 10.1016/s0735-1097(03)00577-1.
Marrouche NF, Martin DO, Wazni O, Gillinov AM, Klein A, Bhargava M, Saad E, Bash D, Yamada H, Jaber W, Schweikert R, Tchou P, Abdul-Karim A, Saliba W, Natale A. Phased-array intracardiac echocardiography monitoring during pulmonary vein isolation in patients with atrial fibrillation: impact on outcome and complications. Circulation. 2003 Jun 3;107(21):2710-6. doi: 10.1161/01.CIR.0000070541.83326.15. Epub 2003 May 19.
Haissaguerre M, Jais P, Shah DC, Arentz T, Kalusche D, Takahashi A, Garrigue S, Hocini M, Peng JT, Clementy J. Catheter ablation of chronic atrial fibrillation targeting the reinitiating triggers. J Cardiovasc Electrophysiol. 2000 Jan;11(1):2-10. doi: 10.1111/j.1540-8167.2000.tb00727.x.
Ullah W, Hunter RJ, Haldar S, McLean A, Dhinoja M, Sporton S, Earley MJ, Lorgat F, Wong T, Schilling RJ. Comparison of robotic and manual persistent AF ablation using catheter contact force sensing: an international multicenter registry study. Pacing Clin Electrophysiol. 2014 Nov;37(11):1427-35. doi: 10.1111/pace.12501. Epub 2014 Sep 15.
Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.
Liu J, Kaufmann J, Kriatselis C, Fleck E, Gerds-Li JH. Second generation of cryoballoons can improve efficiency of cryoablation for atrial fibrillation. Pacing Clin Electrophysiol. 2015 Jan;38(1):129-35. doi: 10.1111/pace.12538. Epub 2014 Dec 12.
Jourda F, Providencia R, Marijon E, Bouzeman A, Hireche H, Khoueiry Z, Cardin C, Combes N, Combes S, Boveda S, Albenque JP. Contact-force guided radiofrequency vs. second-generation balloon cryotherapy for pulmonary vein isolation in patients with paroxysmal atrial fibrillation-a prospective evaluation. Europace. 2015 Feb;17(2):225-31. doi: 10.1093/europace/euu215. Epub 2014 Sep 3.
Ciconte G, Ottaviano L, de Asmundis C, Baltogiannis G, Conte G, Sieira J, Di Giovanni G, Saitoh Y, Irfan G, Mugnai G, Storti C, Montenero AS, Chierchia GB, Brugada P. Pulmonary vein isolation as index procedure for persistent atrial fibrillation: One-year clinical outcome after ablation using the second-generation cryoballoon. Heart Rhythm. 2015 Jan;12(1):60-6. doi: 10.1016/j.hrthm.2014.09.063. Epub 2014 Oct 2.
Other Identifiers
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2016/27
Identifier Type: -
Identifier Source: org_study_id