Real Zero Fluoroscopy Catheter Ablation. (ZERO-Fluoro)

Medical University of Lublin

Status: Unknown

Conditions: Arrhythmia; Arrhythmias, Cardiac; Atrial Arrhythmia; Ventricular Arrythmia

Treatments: Procedure: Conventional ablation without 3D; Procedure: Zero fluoroscopy ablation; Procedure: Conventional ablation with 3D

Study type: Observational

Funder types: Other

Identifiers

NCT03458273

MW-MULublin-2

Details and patient eligibility

About

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

Full 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]

Enrollment: 300 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

Zero fluoro

Description:

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.

Treatment:

Procedure: Zero fluoroscopy ablation

Conventional ablation without 3D

Description:

Patients in whom Conventional fluoroscopy ablation was performed under fluoroscopic guidance only. Additional use of Ensite/Carto/Localisa for mapping was not allowed.

Treatment:

Procedure: Conventional ablation without 3D

Conventional ablation with 3D

Description:

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.

Treatment:

Procedure: Conventional ablation with 3D