Real Zero Fluoroscopy Catheter Ablation.

Arrhythmia Clinical Trial

— ZERO-Fluoro  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03458273
• Other study ID #: MW-MULublin-2
• Status: Recruiting
• Start date: March 10, 2018
• Est. completion date: December 2018

Study information

• Verified date: September 2018
• Source: Medical University of Lublin
• Contact: Maciej Wójcik, MD, PhD
• Phone: +48817244151
• Email: m.wojcik[@]umlub.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmia
• Arrhythmias, Cardiac
• Atrial Arrhythmia
• Ventricular Arrythmia

Intervention

Procedure:
• 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)

Locations

Country	Name	City	State
Poland	Wojewódzki Szpital Specjalistyczn	Biala Podlaska
Poland	Medical University of Lublin	Lublin
Poland	SP ZOZ Szpital Pulawy	Pulawy

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Lublin

Country where clinical trial is conducted

Poland, 

References & Publications (7)

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 — View 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. — View 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. Review. — View 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. Epub 2016 Jun 26. Review. — View 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. Review. — View Citation

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural success rates	arrhythmia recurrence within 3 months since the index procedure	3 months
Secondary	Total procedure time	total procedure time measured as needle to needle time	during procedure
Secondary	Fluoroscopy time	total fluoroscopy time during procedure	during procedure
Secondary	Acute procedural success	acute procedural success defined as arhhythia elimination	10-30 minutes
Secondary	Recurrence rate	arrhythmia recurrence within 6 months since the index procedure	6 months
Secondary	Acute Complications rate	Procedural Complications procedure	during procedure
Secondary	All Complications rate	Procedural Complications and Complications within 6 months since the index procedure	6 months
Secondary	The length of stay during the hospitalization	Number of hospital days for ablation procedure from admission to discharge	1 month