NCT03458273

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

March 10, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

8 months

First QC Date

February 24, 2018

Last Update Submit

September 7, 2018

Conditions

Atrial ArrhythmiaVentricular ArrythmiaArrhythmiaArrhythmias, Cardiac

Keywords

Atrial ArrhythmiaVentricular Arrythmiaablationfluoroscopy

Outcome Measures

Primary Outcomes (1)

  • Procedural success rates

    arrhythmia recurrence within 3 months since the index procedure

    3 months

Secondary Outcomes (7)

  • Total procedure time

    during procedure

  • Fluoroscopy time

    during procedure

  • Acute procedural success

    10-30 minutes

  • Recurrence rate

    6 months

  • Acute Complications rate

    during procedure

  • +2 more secondary outcomes

Study Arms (3)

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

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

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

Interventions

Zero fluoroscopy ablationPROCEDURE

Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance

Also known as: Zero fluoro
Zero fluoro
Conventional ablation without 3DPROCEDURE

Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed

Also known as: Conventional fluoroscopy ablation without 3D
Conventional ablation without 3D
Conventional ablation with 3DPROCEDURE

Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)

Also known as: Conventional fluoroscopy ablation with 3D
Conventional ablation with 3D

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • left atrium arrhythmia
  • left ventricle arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wojewódzki Szpital Specjalistyczn

Biała Podlaska, 21-500, Poland

RECRUITING

Medical University of Lublin

Lublin, 20-091, Poland

RECRUITING

SP ZOZ Szpital Puławy

Puławy, 24-100, Poland

RECRUITING

Related Publications (7)

  • 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.

    PMID: 27639689BACKGROUND

  • 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.

    PMID: 28862408BACKGROUND

  • 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.

    PMID: 27354053BACKGROUND

  • 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.

    PMID: 26462477BACKGROUND

  • 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.

    PMID: 25790320BACKGROUND

  • 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.

    PMID: 27957146BACKGROUND

  • 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.

    PMID: 28159569RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maciej Wójcik, MD, PhD

    Medical University of Lublin, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Wójcik, MD, PhD

CONTACT

+48817244151m.wojcik@umlub.pl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2018

First Posted

March 8, 2018

Study Start

March 10, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

PL(3)