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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Korea University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00959205
First Posted: August 14, 2009
Last Update Posted: May 20, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Korea University
  Purpose
The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

Condition Intervention Phase
Atrial Fibrillation Device: CARTO 3D Device: Angiography Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT

Resource links provided by NLM:


Further study details as provided by Korea University:

Primary Outcome Measures:
  • Fluoroscopic time [ Time Frame: 24weeks ]
    Total duration of procedure using fluoroscopy on , in minute

  • Procedural duration [ Time Frame: 24weeks ]
    Time from after puncture to catheter remover


Secondary Outcome Measures:
  • Ablation time [ Time Frame: 24weeks ]
    Time from to Ablation

  • Procedural Success [ Time Frame: 24weeks ]
    Achievement of the procedure endpoint for each arrhythmia

  • Clinical Success [ Time Frame: 24weeks ]
    • 3 months freedom from recurrence of target arrhythmia
    • > 6 months freedom from recurrence of target arrhythmia

  • Radiation dose [ Time Frame: 24weeks ]
    Calculated dose (in Gray) to the patient as recorded in the laboratory log

  • Morphology of ablation [ Time Frame: 24weeks ]
    Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)

  • Complications [ Time Frame: 24weeks ]
    • procedure and device related adverse event requiring any intervention to prevent permanent medical intervention
    • Important complications are reported individually

  • Cost Effectiveness [ Time Frame: 24weeks ]
  • Survival Rate [ Time Frame: 24weeks ]

Estimated Enrollment: 160
Study Start Date: July 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Angiography
Conventional fluoroscopically guided activation mapping
Device: Angiography
Conventional fluoroscopically guided activation mapping
Other Name: Celsius
Experimental: CARTO 3D
CARTO (3D Electroanatomic imaging)
Device: CARTO 3D
CARTO (3D Electroanatomic imaging)

Detailed Description:
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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with AF or substrate-dependent VT

Exclusion Criteria:

  • administering with anticoagulants
  Contacts and Locations
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): NCT00959205


Locations
Korea, Republic of
Korea medical center
Seoul, Korea, Republic of, 136-705
Asan Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital/Internal Medicine
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Kim Young-Hoon, MD, PhD Korea medical center
  More Information

Responsible Party: Young-Hoon Kim, Korea medical center
ClinicalTrials.gov Identifier: NCT00959205     History of Changes
Other Study ID Numbers: 2009_KU_CARTO
First Submitted: August 13, 2009
First Posted: August 14, 2009
Last Update Posted: May 20, 2010
Last Verified: August 2009

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes