Real Zero Fluoroscopy Catheter Ablation. (ZERO-Fluoro)

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ClinicalTrials.gov Identifier: NCT03458273

Recruitment Status : Unknown

Verified September 2018 by Maciej Wójcik, MD, PhD, Medical University of Lublin.
Recruitment status was: Recruiting

First Posted : March 8, 2018

Last Update Posted : September 10, 2018

Sponsor:

Information provided by (Responsible Party):

Maciej Wójcik, MD, PhD, Medical University of Lublin

Study Description

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

Condition or disease	Intervention/treatment
Atrial Arrhythmia Ventricular Arrythmia Arrhythmia Arrhythmias, Cardiac	Procedure: Zero fluoroscopy ablation Procedure: Conventional ablation without 3D Procedure: Conventional ablation with 3D

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]

Study Design

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Study Type :	Observational
Estimated Enrollment :	300 participants
Observational Model:	Case-Control
Time Perspective:	Retrospective
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
Actual Study Start Date :	March 10, 2018
Estimated Primary Completion Date :	November 2018
Estimated Study Completion Date :	December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Procedure: Zero fluoroscopy ablation Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance Other Name: Zero fluoro
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.	Procedure: 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 Other Name: Conventional fluoroscopy ablation without 3D
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.	Procedure: Conventional ablation with 3D Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto) Other Name: Conventional fluoroscopy ablation with 3D

Outcome Measures

Primary Outcome Measures :

Procedural success rates [ Time Frame: 3 months ]
arrhythmia recurrence within 3 months since the index procedure

Secondary Outcome Measures :

Total procedure time [ Time Frame: during procedure ]
total procedure time measured as needle to needle time
Fluoroscopy time [ Time Frame: during procedure ]
total fluoroscopy time during procedure
Acute procedural success [ Time Frame: 10-30 minutes ]
acute procedural success defined as arhhythia elimination
Recurrence rate [ Time Frame: 6 months ]
arrhythmia recurrence within 6 months since the index procedure
Acute Complications rate [ Time Frame: during procedure ]
Procedural Complications procedure
All Complications rate [ Time Frame: 6 months ]
Procedural Complications and Complications within 6 months since the index procedure
The length of stay during the hospitalization [ Time Frame: 1 month ]
Number of hospital days for ablation procedure from admission to discharge

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458273

Contacts

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Contact: Maciej Wójcik, MD, PhD	+48817244151	m.wojcik@umlub.pl

Locations

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Poland
Wojewódzki Szpital Specjalistyczn	Recruiting
Biała Podlaska, Poland, 21-500
Contact: Maciej Wójcik, MD,PhD +48817244151 m.wojcik@umlub.pl
Medical University of Lublin	Recruiting
Lublin, Poland, 20-091
Contact: Maciej Wójcik, MD, PhD +48817244151 m.wojcik@umlub.pl
SP ZOZ Szpital Puławy	Recruiting
Puławy, Poland, 24-100
Contact: Maciej Wójcik, MD, PhD +48817244151 m.wojcik@umlub.pl

Sponsors and Collaborators

Medical University of Lublin

Investigators

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Principal Investigator:	Maciej Wójcik, MD, PhD	Medical University of Lublin, Poland

More Information

Publications of Results:

Álvarez M, Bertomeu-González V, Arcocha MF, Moriña P, Tercedor L, Ferrero de Loma Á, Pachón M, García 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 Publications:

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. Review.

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. Review.

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. Epub 2016 Jun 26. Review.

Seizer P, Bucher V, Frische C, Heinzmann D, Gramlich M, Müller 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. Review.

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Responsible Party:	Maciej Wójcik, MD, PhD, Associate Professor, Medical University of Lublin
ClinicalTrials.gov Identifier:	NCT03458273
Other Study ID Numbers:	MW-MULublin-2
First Posted:	March 8, 2018 Key Record Dates
Last Update Posted:	September 10, 2018
Last Verified:	September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Maciej Wójcik, MD, PhD, Medical University of Lublin:


Atrial Arrhythmia Ventricular Arrythmia ablation fluoroscopy

Additional relevant MeSH terms:

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Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes

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