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

Phase 4

• Conditions: Atrial Fibrillation
• Interventions: Device: Angiography; Device: CARTO 3D

• Registration Number: NCT00959205
• Lead Sponsor: Korea University

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

Study Timeline

• Study Start: 2009-07
• Status Verified: 2009-08
• Study First Submitted: 2009-08-13
• Study First Submitted QC: 2009-08-13
• Study First Posted: 2009-08-14
• Last Update Submitted: 2010-05-19
• Last Update Posted: 2010-05-20
• Primary Completion: 2010-06
• Study Completion: 2011-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• patients with AF or substrate-dependent VT

Exclusion Criteria

• administering with anticoagulants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Angiography	Angiography	Conventional fluoroscopically guided activation mapping
CARTO 3D	CARTO 3D	CARTO (3D Electroanatomic imaging)

Primary Outcome Measures

Name	Time	Method
Procedural duration	24weeks	Time from after puncture to catheter remover
Fluoroscopic time	24weeks	Total duration of procedure using fluoroscopy on , in minute

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Korea medical center; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital/Internal Medicine; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of