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Real Zero Fluoroscopy Catheter Ablation. (ZERO-Fluoro)

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ClinicalTrials.gov Identifier: NCT03458273
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Maciej Wójcik, MD, PhD, Medical University of Lublin

Tracking Information
First Submitted Date February 24, 2018
First Posted Date March 8, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date March 10, 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2018)
Procedural success rates [ Time Frame: 3 months ]
arrhythmia recurrence within 3 months since the index procedure
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03458273 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 1, 2018)
  • Total procedure time [ Time Frame: during procedure ]
    total procedure time measured as needle to needle time
  • Fluoroscopy time [ Time Frame: during procedure ]
    total fluoroscopy time during procedure
  • Acute procedural success [ Time Frame: 10-30 minutes ]
    acute procedural success defined as arhhythia elimination
  • Recurrence rate [ Time Frame: 6 months ]
    arrhythmia recurrence within 6 months since the index procedure
  • Acute Complications rate [ Time Frame: during procedure ]
    Procedural Complications procedure
  • All Complications rate [ Time Frame: 6 months ]
    Procedural Complications and Complications within 6 months since the index procedure
  • The length of stay during the hospitalization [ Time Frame: 1 month ]
    Number of hospital days for ablation procedure from admission to discharge
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real Zero Fluoroscopy Catheter Ablation.
Official Title 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
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 Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition
  • Atrial Arrhythmia
  • Ventricular Arrythmia
  • Arrhythmia
  • Arrhythmias, Cardiac
Intervention
  • Procedure: Zero fluoroscopy ablation
    Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance
    Other Name: Zero fluoro
  • 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 Name: Conventional fluoroscopy ablation without 3D
  • Procedure: Conventional ablation with 3D
    Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)
    Other Name: Conventional fluoroscopy ablation with 3D
Study Groups/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.
    Intervention: 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.

    Intervention: 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.

    Intervention: Procedure: Conventional ablation with 3D
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 1, 2018)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Maciej Wójcik, MD, PhD +48817244151 m.wojcik@umlub.pl
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT03458273
Other Study ID Numbers MW-MULublin-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Maciej Wójcik, MD, PhD, Medical University of Lublin
Study Sponsor Medical University of Lublin
Collaborators Not Provided
Investigators
Principal Investigator: Maciej Wójcik, MD, PhD Medical University of Lublin, Poland
PRS Account Medical University of Lublin
Verification Date September 2018