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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UNKNOWN
300 participants
OBSERVATIONAL
2018-03-10
2018-12-31
Brief Summary
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* real zero fluoroscopy catheter ablation
* conventional fluoroscopy catheter ablation without 3D system
* conventional fluoroscopy catheter ablation with 3D system
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Detailed Description
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The study is an investigator-initiated, retrospective analysis of prospectively collected data. The study population consists of patients with right-sided arrhythmias who underwent zero-fluoroscopy catheter ablation between the years 2016 and 2018 in 3 centers and a propensity score matched patients group of patients who:
* underwent conventional fluoroscopy guided catheter ablation without 3D system (Ensite/Carto) support
* underwent conventional fluoroscopy guided catheter ablation with 3D system (Ensite/Carto) support
Covariates for matching will be:
* arrhythmia type
* age of a patient
* number of diagnostic catheters used during a procedure
* type of a diagnostic catheter used during a procedure\]
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Zero fluoro
Patients in whom Zero fluoroscopy ablation was performed under the guidance of Ensite for mapping and ablation and fluoroscopy will not be used during the procedure.
Zero fluoroscopy ablation
Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance
Conventional ablation without 3D
Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic guidance only.
Additional use of Ensite/Carto/Localisa for mapping was not allowed.
Conventional ablation without 3D
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed
Conventional ablation with 3D
Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic and Ensite/Carto guidance and ablation during the procedure.
Use of fluoroscopy and additional Ensite/Carto for mapping and ablation was mandatory.
Conventional ablation with 3D
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)
Interventions
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Zero fluoroscopy ablation
Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance
Conventional ablation without 3D
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed
Conventional ablation with 3D
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* right atrial premature complexes
* AVNRT
* right atrial AVRT/WPW
* right ventricle tachycardia / right ventricle premature complexes
Exclusion Criteria
* left ventricle arrhythmia
16 Years
ALL
No
Sponsors
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Medical University of Lublin
OTHER
Responsible Party
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Maciej Wójcik, MD, PhD
Associate Professor
Principal Investigators
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Maciej Wójcik, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Lublin, Poland
Locations
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Wojewódzki Szpital Specjalistyczn
Biała Podlaska, , Poland
Medical University of Lublin
Lublin, , Poland
SP ZOZ Szpital Puławy
Puławy, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Yang L, Sun G, Chen X, Chen G, Yang S, Guo P, Wang Y, Wang DW. Meta-Analysis of Zero or Near-Zero Fluoroscopy Use During Ablation of Cardiac Arrhythmias. Am J Cardiol. 2016 Nov 15;118(10):1511-1518. doi: 10.1016/j.amjcard.2016.08.014. Epub 2016 Aug 24.
Casella M, Ribatti V, Catto V, Vettor G, Fassini G, Biagioli V, Dello Russo A, Tondo C. Benefits of electroanatomic ablation of conventional cardiac arrhytmias: from fluoroscopy to zero X-ray mapping. Minerva Cardioangiol. 2018 Feb;66(1):49-62. doi: 10.23736/S0026-4725.17.04478-4. Epub 2017 Aug 31.
Gaita F, Guerra PG, Battaglia A, Anselmino M. The dream of near-zero X-rays ablation comes true. Eur Heart J. 2016 Sep 21;37(36):2749-2755. doi: 10.1093/eurheartj/ehw223. Epub 2016 Jun 26.
Seizer P, Bucher V, Frische C, Heinzmann D, Gramlich M, Muller I, Henning A, Hofbeck M, Kerst G, Gawaz M, Schreieck J. Efficacy and safety of zero-fluoroscopy ablation for supraventricular tachycardias. Use of optional contact force measurement for zero-fluoroscopy ablation in a clinical routine setting. Herz. 2016 May;41(3):241-5. doi: 10.1007/s00059-015-4358-4. Epub 2015 Oct 13.
Bulava A, Hanis J, Eisenberger M. Catheter Ablation of Atrial Fibrillation Using Zero-Fluoroscopy Technique: A Randomized Trial. Pacing Clin Electrophysiol. 2015 Jul;38(7):797-806. doi: 10.1111/pace.12634. Epub 2015 Apr 16.
Scaglione M, Ebrille E, Clemente FD, Gaita F, Bradfield JS. Catheter Ablation of Atrial Fibrillation Without Radiation Exposure Using A 3D Mapping System. J Atr Fibrillation. 2015 Feb 28;7(5):1167. doi: 10.4022/jafib.1167. eCollection 2015 Feb-Mar.
Alvarez M, Bertomeu-Gonzalez V, Arcocha MF, Morina P, Tercedor L, Ferrero de Loma A, Pachon M, Garcia A, Pardo M, Datino T, Alonso C, Osca J; investigators of the Spanish Multicenter Registry of Fluoroscopy-free Ablation. Nonfluoroscopic Catheter Ablation. Results From a Prospective Multicenter Registry. Rev Esp Cardiol (Engl Ed). 2017 Sep;70(9):699-705. doi: 10.1016/j.rec.2016.12.040. Epub 2017 Jan 31. English, Spanish.
Other Identifiers
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MW-MULublin-2
Identifier Type: -
Identifier Source: org_study_id
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