Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
| University Hospital of North Norway | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will compare efficacy and safety of pulmonary vein isolation using a cryoballoon catheter versus a radiofrequency ablation with a contact force sensing catheter for treatment of patients with persistent or longstanding persistent atrial fibrillation.
The purpose of this randomized clinical trial is to compare the efficacy and safety of pulmonary vein isolation with either the second generation cryoballoon (Arctic Front Advanceâ„¢) or a radiofrequency ablation technique with an irrigated ablation catheter (TactiCathâ„¢ Quartz) . A total of 128 patients with persistent or longstanding persistent atrial fibrillation will be randomized for either radiofrequency or cryoballoon ablation treatment. With both techniques, pulmonary vein isolation will be performed and confirmed by a circular mapping catheter. The primary endpoint is freedom of any atrial arrhythmia recurrence at 12 months.Treatment success will be evaluated by using 12-lead electrocardiography and 7-day Holter recording.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryoballoon | Active Comparator | Pulmonary vein isolation with cryoballoon catheter. |
|
| Radiofrequency | Active Comparator | Pulmonary vein isolation with radiofrequency ablation catheter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary vein isolation with cryoballoon catheter. | Procedure | Device: Arctic Front Advanceâ„¢ cardiac cryoablation catheter system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The freedom of any atrial arrhythmias at 12 months. | The primary endpoint is freedom of any atrial arrhythmias at 12 months (at least one episode of atrial fibrillation, or atrial flutter or atrial tachycardia with a duration > 30 seconds documented by 7-day Holter ECG, or any other printed ECG recording). | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure duration | Procedure duration documented | 12 months |
| Fluoroscopy time | Fluoroscopy time documented | 12 months |
Not provided
Inclusion criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Norway | ||||
| University Hospital of North Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8903269 | Background | Camm AJ, Obel OA. Epidemiology and mechanism of atrial fibrillation and atrial flutter. Am J Cardiol. 1996 Oct 17;78(8A):3-11. doi: 10.1016/s0002-9149(96)00559-0. No abstract available. | |
| 11165976 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pulmonary vein isolation with radiofrequency ablation. | Procedure | Device: TactiCathâ„¢ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical). |
|
| Ablation time | Ablation time documented | 12 months |
| Quality of life - Short Form (SF-36) Heath Survey | Short Form (SF-36) Heath Survey filled in by patients. | 12 months. |
| Quality of life affected by atrial fibrillation. | The Atrial Fibrillation Effect on Quality-of-life (AFEQT) questionnaire will be filled in by patients. | 12 months. |
| Admittance to hospital or emergency services due to symptoms caused by documented atrial arrhythmias. | Hospitalization after the procedre | 12 months. |
| The burden of atrial fibrillation | Total duration of atrial fibrillation recorded by 7-day Holter. | 12 months. |
| The occurrence of documented left atrial tachycardia and typical or atypical atrial flutter. | Atrial tachycardia or atrial flutter recorded by all types of ECG | 12 months. |
| Symptoms related to atrial fibrillation. | Symptoms related to atrial fibrillation documented | 12 months. |
| Serious adverse events. | Serious adverse events documented | 12 months. |
| Tromsø |
| Norway |
| St Olavs Hospital | Trondheim | Norway |
| 12401530 | Background | 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. |
| 9737513 | Background | 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. |
| 9472202 | Background | 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. |
| 15007003 | Background | 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. |
| 9725923 | Background | 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. |
| 15574190 | Background | 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. |
| 14557355 | Background | 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. |
| 14623799 | Background | 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. |
| 12875749 | Background | 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. |
| 12756153 | Background | 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. |
| 10695453 | Background | 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. |
| 25220575 | Background | 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. |
| 25946280 | Background | 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. |
| 25494851 | Background | 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. |
| 25186456 | Background | 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. |
| 25281891 | Background | 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided