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

Atrial Fibrillation Clinical Trial

— CARTOAF&VT  

Official title:

Phase Ⅳ Study of CARTO 3D Mapping System vs Conventional Method in AF & VT

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00959205
• Other study ID #: 2009_KU_CARTO
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: August 13, 2009
• Last updated: May 19, 2010
• Start date: July 2009
• Est. completion date: February 2011

Study information

• Verified date: August 2009
• Source: Korea University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of electroanatomic imaging compared to conventional method in patients with VT.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: February 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

Inclusion Criteria:

• patients with AF or substrate-dependent VT

Exclusion Criteria:

• administering with anticoagulants

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• CARTO 3D
CARTO (3D Electroanatomic imaging)
• Angiography
Conventional fluoroscopically guided activation mapping

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea 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

Sponsors (1)

Lead Sponsor	Collaborator
Korea University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluoroscopic time	Total duration of procedure using fluoroscopy on , in minute	24weeks	Yes
Primary	Procedural duration	Time from after puncture to catheter remover	24weeks	No
Secondary	Ablation time	Time from to Ablation	24weeks	No
Secondary	Procedural Success	Achievement of the procedure endpoint for each arrhythmia	24weeks	No
Secondary	Clinical Success	3 months freedom from recurrence of target arrhythmia; > 6 months freedom from recurrence of target arrhythmia	24weeks	No
Secondary	Radiation dose	Calculated dose (in Gray) to the patient as recorded in the laboratory log	24weeks	Yes
Secondary	Morphology of ablation	Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)	24weeks	No
Secondary	Complications	procedure and device related adverse event requiring any intervention to prevent permanent medical intervention; Important complications are reported individually	24weeks	Yes
Secondary	Cost Effectiveness		24weeks	No
Secondary	Survival Rate		24weeks	Yes