Back to resultsThe Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT (CARTOAF&VT)
Primary Purpose
Atrial Fibrillation
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CARTO 3D
Angiography
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- patients with AF or substrate-dependent VT
Exclusion Criteria:
- administering with anticoagulants
Sites / Locations
- Korea medical center
- Asan Medical Center
- Seoul National University Hospital/Internal Medicine
- Seoul St. Mary's Hospital
- Severance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Angiography
CARTO 3D
Arm Description
Conventional fluoroscopically guided activation mapping
CARTO (3D Electroanatomic imaging)
Outcomes
Primary Outcome Measures
Fluoroscopic time
Total duration of procedure using fluoroscopy on , in minute
Procedural duration
Time from after puncture to catheter remover
Secondary Outcome Measures
Ablation time
Time from to Ablation
Procedural Success
Achievement of the procedure endpoint for each arrhythmia
Clinical Success
3 months freedom from recurrence of target arrhythmia
> 6 months freedom from recurrence of target arrhythmia
Radiation dose
Calculated dose (in Gray) to the patient as recorded in the laboratory log
Morphology of ablation
Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)
Complications
procedure and device related adverse event requiring any intervention to prevent permanent medical intervention
Important complications are reported individually
Cost Effectiveness
Survival Rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00959205
Brief Title
The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT
Acronym
CARTOAF&VT
Official Title
Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
February 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Korea University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Angiography
Arm Type
Active Comparator
Arm Description
Conventional fluoroscopically guided activation mapping
Arm Title
CARTO 3D
Arm Type
Experimental
Arm Description
CARTO (3D Electroanatomic imaging)
Intervention Type
Device
Intervention Name(s)
CARTO 3D
Intervention Description
CARTO (3D Electroanatomic imaging)
Intervention Type
Device
Intervention Name(s)
Angiography
Other Intervention Name(s)
Celsius
Intervention Description
Conventional fluoroscopically guided activation mapping
Primary Outcome Measure Information:
Title
Fluoroscopic time
Description
Total duration of procedure using fluoroscopy on , in minute
Time Frame
24weeks
Title
Procedural duration
Description
Time from after puncture to catheter remover
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
Ablation time
Description
Time from to Ablation
Time Frame
24weeks
Title
Procedural Success
Description
Achievement of the procedure endpoint for each arrhythmia
Time Frame
24weeks
Title
Clinical Success
Description
3 months freedom from recurrence of target arrhythmia
> 6 months freedom from recurrence of target arrhythmia
Time Frame
24weeks
Title
Radiation dose
Description
Calculated dose (in Gray) to the patient as recorded in the laboratory log
Time Frame
24weeks
Title
Morphology of ablation
Description
Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)
Time Frame
24weeks
Title
Complications
Description
procedure and device related adverse event requiring any intervention to prevent permanent medical intervention
Important complications are reported individually
Time Frame
24weeks
Title
Cost Effectiveness
Time Frame
24weeks
Title
Survival Rate
Time Frame
24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with AF or substrate-dependent VT
Exclusion Criteria:
administering with anticoagulants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Young-Hoon, MD, PhD
Organizational Affiliation
Korea medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea medical center
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital/Internal Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The Efficacy and Safety of CARTO 3D Mapping System Versus Conventional Method in AF and VT
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