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Status unknownNCT03458273ZERO-FluoroUpdated Sep 10, 2018

Real Zero Fluoroscopy Catheter Ablation.

An observational study in Atrial Arrhythmia, Ventricular Arrythmia and Arrhythmia, sponsored by Medical University of Lublin. Status unknown at 3 sites in Poland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Medical University of Lublin · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
300
Ages
16 Years and older
Sex
All
01

Study 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
Read the 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]
02

Conditions studied

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

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Keywords

  • Atrial Arrhythmia
  • Ventricular Arrythmia
  • ablation
  • fluoroscopy
03

Who can participate

Ages eligible
16 Years and older
Sexes eligible
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • left atrium arrhythmia
  • left ventricle arrhythmia
04

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureZero fluoroscopy ablation

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

    Also known as: Zero fluoro

  • ProcedureConventional ablation without 3D

    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

  • ProcedureConventional ablation with 3D

    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

05

What researchers measure

Primary outcomes

  1. Procedural success rates

    arrhythmia recurrence within 3 months since the index procedure

    Time frame: 3 months

Secondary outcomes

  1. Total procedure time

    total procedure time measured as needle to needle time

    Time frame: during procedure

  2. Fluoroscopy time

    total fluoroscopy time during procedure

    Time frame: during procedure

  3. Acute procedural success

    acute procedural success defined as arhhythia elimination

    Time frame: 10-30 minutes

  4. Recurrence rate

    arrhythmia recurrence within 6 months since the index procedure

    Time frame: 6 months

  5. Acute Complications rate

    Procedural Complications procedure

    Time frame: during procedure

  6. All Complications rate

    Procedural Complications and Complications within 6 months since the index procedure

    Time frame: 6 months

  7. The length of stay during the hospitalization

    Number of hospital days for ablation procedure from admission to discharge

    Time frame: 1 month

06

Study locations

3 of 3 sites recruiting
  • 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
07

References and documents

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. PubMed 27639689 ↗
  • 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. PubMed 28862408 ↗
  • 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. PubMed 27354053 ↗
  • 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. PubMed 26462477 ↗
  • 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. PubMed 25790320 ↗
  • 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. PubMed 27957146 ↗
  • 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. PubMed 28159569 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03458273
Lead sponsor
Medical University of Lublin
Responsible party
Maciej Wójcik, MD, PhD (Associate Professor, Medical University of Lublin) — Principal investigator
First posted
Mar 8, 2018
Start date
Mar 10, 2018
Primary completion
Nov 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Sep 10, 2018

Study contacts

Maciej Wójcik, MD, PhD
Contact
m.wojcik@umlub.pl
+48817244151
Maciej Wójcik, MD, PhD
principal investigator · Medical University of Lublin, Poland

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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