Clinical trial NCT03458273: Real Zero Fluoroscopy Catheter Ablation.
Official title: Multi-center, Observational, Retrospective Comparison of the Feasibility, Safety, and Efficacy of Real Zero Fluoroscopy Versus Conventional Fluoroscopic Catheter Ablation With and Without 3D System Support: Propensity Matched Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Arrhythmia
Ventricular Arrythmia
Arrhythmia
Arrhythmias, Cardiac
Keywords: Atrial Arrhythmia
Ventricular Arrythmia
ablation
fluoroscopy
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Zero fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with 3D (Ensite/Carto) guidance but without fluoroscopy guidance

Convectional fluoroscopy group: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance but without 3D (Ensite/Carto) guidance

Convectional fluoroscopy group + 3D: patients after right atrium/ventricle arrhythmia ablation performed with fluoroscopy guidance and with 3D (Ensite/Carto) guidance

Brief summary: A Retrospective Propensity Matched Study comparing:

* real zero fluoroscopy catheter ablation
* conventional fluoroscopy catheter ablation without 3D system
* conventional fluoroscopy catheter ablation with 3D system

Detailed description: Catheter ablation is a well-established treatment to treat patients with a wide scope of heart arrhythmias.

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\]

Eligibility criteria: Inclusion Criteria:

* right atrial tachycardia
* right atrial premature complexes
* AVNRT
* right atrial AVRT/WPW
* right ventricle tachycardia / right ventricle premature complexes

Exclusion Criteria:

* left atrium arrhythmia
* left ventricle arrhythmia

Primary outcomes:
measure: Procedural success rates
timeFrame: 3 months
Secondary outcomes:
measure: Total procedure time
timeFrame: during procedure
measure: Fluoroscopy time
timeFrame: during procedure
measure: Acute procedural success
timeFrame: 10-30 minutes
measure: Recurrence rate
timeFrame: 6 months
measure: Acute Complications rate
timeFrame: during procedure
measure: All Complications rate
timeFrame: 6 months
measure: The length of stay during the hospitalization
timeFrame: 1 month
Other outcomes:
Locations:
city: Biała Podlaska
country: Poland
facility: Wojewódzki Szpital Specjalistyczn
city: Lublin
country: Poland
facility: Medical University of Lublin
city: Puławy
country: Poland
facility: SP ZOZ Szpital Puławy
Study officials:
affiliation: Medical University of Lublin, Poland
name: Maciej Wójcik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.