The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT (CARTOAF&VT)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00959205
First received: August 13, 2009
Last updated: May 19, 2010
Last verified: August 2009

August 13, 2009
May 19, 2010
July 2009
June 2010   (final data collection date for primary outcome measure)
  • Fluoroscopic time [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
    Total duration of procedure using fluoroscopy on , in minute
  • Procedural duration [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    Time from after puncture to catheter remover
Not Provided
Complete list of historical versions of study NCT00959205 on ClinicalTrials.gov Archive Site
  • Ablation time [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    Time from to Ablation
  • Procedural Success [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    Achievement of the procedure endpoint for each arrhythmia
  • Clinical Success [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    • 3 months freedom from recurrence of target arrhythmia
    • > 6 months freedom from recurrence of target arrhythmia
  • Radiation dose [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
    Calculated dose (in Gray) to the patient as recorded in the laboratory log
  • Morphology of ablation [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
    Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)
  • Complications [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
    • procedure and device related adverse event requiring any intervention to prevent permanent medical intervention
    • Important complications are reported individually
  • Cost Effectiveness [ Time Frame: 24weeks ] [ Designated as safety issue: No ]
  • Survival Rate [ Time Frame: 24weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT
Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT

The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

To evaluate the efficacy and safety of electroanatomic imaging (CARTO) compared to conventional fluoroscopically guided activation mapping (Conventional) method in patients with Atrial Fibrillation and Substrate-dependent Ventricular Tachycardia To evaluate cost-effectiveness of CARTO 3D image system compared to conventional method in the same study subjects

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Atrial Fibrillation
  • Device: CARTO 3D
    CARTO (3D Electroanatomic imaging)
    Other Name: CARTO 3D
  • Device: Angiography
    Conventional fluoroscopically guided activation mapping
    Other Name: Celsius
  • Active Comparator: Angiography
    Conventional fluoroscopically guided activation mapping
    Intervention: Device: Angiography
  • Experimental: CARTO 3D
    CARTO (3D Electroanatomic imaging)
    Intervention: Device: CARTO 3D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
160
February 2011
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with AF or substrate-dependent VT

Exclusion Criteria:

  • administering with anticoagulants
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00959205
2009_KU_CARTO
Yes
Young-Hoon Kim, Korea medical center
Korea University
Not Provided
Principal Investigator: Kim Young-Hoon, MD, PhD Korea medical center
Korea University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP