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Real Zero Fluoroscopy Catheter Ablation.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03458273
Acronym
ZERO-Fluoro
Enrollment
300
Registered
2018-03-08
Start date
2018-03-10
Completion date
2018-12-31
Last updated
2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Arrhythmias, Cardiac, Atrial Arrhythmia, Ventricular Arrythmia

Keywords

Atrial Arrhythmia, Ventricular Arrythmia, ablation, fluoroscopy

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\]

Interventions

PROCEDUREZero fluoroscopy ablation

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

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

PROCEDUREConventional ablation with 3D

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

Sponsors

Medical University of Lublin
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Procedural success rates3 monthsarrhythmia recurrence within 3 months since the index procedure

Secondary

MeasureTime frameDescription
Fluoroscopy timeduring proceduretotal fluoroscopy time during procedure
Acute procedural success10-30 minutesacute procedural success defined as arhhythia elimination
Recurrence rate6 monthsarrhythmia recurrence within 6 months since the index procedure
Total procedure timeduring proceduretotal procedure time measured as needle to needle time
All Complications rate6 monthsProcedural Complications and Complications within 6 months since the index procedure
The length of stay during the hospitalization1 monthNumber of hospital days for ablation procedure from admission to discharge
Acute Complications rateduring procedureProcedural Complications procedure

Countries

Poland

Contacts

Primary ContactMaciej Wójcik, MD, PhD
m.wojcik@umlub.pl+48817244151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026