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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 ] [ 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


Secondary Outcome Measures:
  • 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 ]

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)
Other Name: CARTO 3D

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with AF or substrate-dependent VT

Exclusion Criteria:

  • administering with anticoagulants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959205

Locations
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Korea medical center
Seoul, Korea, Republic of, 136-705
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

No publications provided

Responsible Party: Young-Hoon Kim, Korea medical center
ClinicalTrials.gov Identifier: NCT00959205     History of Changes
Other Study ID Numbers: 2009_KU_CARTO
Study First Received: August 13, 2009
Last Updated: May 19, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 23, 2014