Real Zero Fluoroscopy Catheter Ablation.

• Conditions: Atrial Arrhythmia; Ventricular Arrythmia; Arrhythmias, Cardiac; Arrhythmia
• Interventions: Procedure: Conventional ablation without 3D; Procedure: Zero fluoroscopy ablation; Procedure: Conventional ablation with 3D

• Registration Number: NCT03458273
• Lead Sponsor: Medical University of Lublin

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\]

Study Timeline

• Study First Submitted: 2018-02-24
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-08
• Study Start: 2018-03-10
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-10
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional ablation without 3D	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.
Zero fluoro	Zero fluoroscopy ablation	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.
Conventional ablation with 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.

Primary Outcome Measures

Name	Time	Method
Procedural success rates	3 months	arrhythmia recurrence within 3 months since the index procedure

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Wojewódzki Szpital Specjalistyczn; 🇵🇱 Biała Podlaska, Poland

Medical University of Lublin; 🇵🇱 Lublin, Poland

SP ZOZ Szpital Puławy; 🇵🇱 Puławy, Poland