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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

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

Condition or disease Intervention/treatment
Atrial Arrhythmia Ventricular Arrythmia Arrhythmia Arrhythmias, Cardiac Procedure: Zero fluoroscopy ablation Procedure: Conventional ablation without 3D Procedure: Conventional ablation with 3D

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]

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : March 10, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

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 Name: 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 Name: 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 Name: Conventional fluoroscopy ablation with 3D




Primary Outcome Measures :
  1. Procedural success rates [ Time Frame: 3 months ]
    arrhythmia recurrence within 3 months since the index procedure


Secondary Outcome Measures :
  1. Total procedure time [ Time Frame: during procedure ]
    total procedure time measured as needle to needle time

  2. Fluoroscopy time [ Time Frame: during procedure ]
    total fluoroscopy time during procedure

  3. Acute procedural success [ Time Frame: 10-30 minutes ]
    acute procedural success defined as arhhythia elimination

  4. Recurrence rate [ Time Frame: 6 months ]
    arrhythmia recurrence within 6 months since the index procedure

  5. Acute Complications rate [ Time Frame: during procedure ]
    Procedural Complications procedure

  6. All Complications rate [ Time Frame: 6 months ]
    Procedural Complications and Complications within 6 months since the index procedure

  7. The length of stay during the hospitalization [ Time Frame: 1 month ]
    Number of hospital days for ablation procedure from admission to discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458273


Contacts
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Contact: Maciej Wójcik, MD, PhD +48817244151 m.wojcik@umlub.pl

Locations
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Poland
Wojewódzki Szpital Specjalistyczn Recruiting
Biała Podlaska, Poland, 21-500
Contact: Maciej Wójcik, MD,PhD    +48817244151    m.wojcik@umlub.pl   
Medical University of Lublin Recruiting
Lublin, Poland, 20-091
Contact: Maciej Wójcik, MD, PhD    +48817244151    m.wojcik@umlub.pl   
SP ZOZ Szpital Puławy Recruiting
Puławy, Poland, 24-100
Contact: Maciej Wójcik, MD, PhD    +48817244151    m.wojcik@umlub.pl   
Sponsors and Collaborators
Medical University of Lublin
Investigators
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Principal Investigator: Maciej Wójcik, MD, PhD Medical University of Lublin, Poland

Publications of Results:
Other Publications:

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Responsible Party: Maciej Wójcik, MD, PhD, Associate Professor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03458273     History of Changes
Other Study ID Numbers: MW-MULublin-2
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maciej Wójcik, MD, PhD, Medical University of Lublin:
Atrial Arrhythmia
Ventricular Arrythmia
ablation
fluoroscopy
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes