Real Zero Fluoroscopy Catheter Ablation. (ZERO-Fluoro)

September 7, 2018 updated by: Maciej Wójcik, MD, PhD, Medical University of Lublin

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Biała Podlaska, Poland, 21-500
        • Recruiting
        • Wojewódzki Szpital Specjalistyczn
        • Contact:
      • Lublin, Poland, 20-091
        • Recruiting
        • Medical University of Lublin
      • Puławy, Poland, 24-100
        • Recruiting
        • SP ZOZ Szpital Puławy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance
Other Names:
  • Zero fluoro
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
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed
Other Names:
  • Conventional fluoroscopy 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
Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)
Other Names:
  • Conventional fluoroscopy ablation with 3D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural success rates
Time Frame: 3 months
arrhythmia recurrence within 3 months since the index procedure
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 10, 2018

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

February 24, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (ACTUAL)

March 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2018

Last Update Submitted That Met QC Criteria

September 7, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MW-MULublin-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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