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

May 19, 2010 updated by: Korea University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Seoul St. Mary'S Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital
      • Seoul, Korea, Republic of, 136-705
        • Korea medical center
      • Seoul, Korea, Republic of
        • Seoul National University Hospital/Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with AF or substrate-dependent VT

Exclusion Criteria:

  • administering with anticoagulants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Angiography
Conventional fluoroscopically guided activation mapping
Device: Angiography
Conventional fluoroscopically guided activation mapping
Other Names:
  • Celsius
Experimental: CARTO 3D
CARTO (3D Electroanatomic imaging)
Device: CARTO 3D
CARTO (3D Electroanatomic imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fluoroscopic time
Time Frame: 24weeks
Total duration of procedure using fluoroscopy on , in minute
24weeks
Procedural duration
Time Frame: 24weeks
Time from after puncture to catheter remover
24weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ablation time
Time Frame: 24weeks
Time from to Ablation
24weeks
Procedural Success
Time Frame: 24weeks
Achievement of the procedure endpoint for each arrhythmia
24weeks
Clinical Success
Time Frame: 24weeks
  • 3 months freedom from recurrence of target arrhythmia
  • > 6 months freedom from recurrence of target arrhythmia
24weeks
Radiation dose
Time Frame: 24weeks
Calculated dose (in Gray) to the patient as recorded in the laboratory log
24weeks
Morphology of ablation
Time Frame: 24weeks
Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)
24weeks
Complications
Time Frame: 24weeks
  • procedure and device related adverse event requiring any intervention to prevent permanent medical intervention
  • Important complications are reported individually
24weeks
Cost Effectiveness
Time Frame: 24weeks
24weeks
Survival Rate
Time Frame: 24weeks
24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea University

Investigators

  • Principal Investigator: Kim Young-Hoon, MD, PhD, Korea medical center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2010

Last Update Submitted That Met QC Criteria

May 19, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009_KU_CARTO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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