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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959205

Acronym

CARTOAF&VT

Enrollment

160

Registered

2009-08-14

Start date

2009-07-31

Completion date

2011-02-28

Last updated

2010-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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

Interventions

DEVICEAngiography

Conventional fluoroscopically guided activation mapping

DEVICECARTO 3D

CARTO (3D Electroanatomic imaging)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

Inclusion criteria

* patients with AF or substrate-dependent VT

Exclusion criteria

* administering with anticoagulants

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
Morphology of ablation	24weeks	Number of Gap and the distance from the ostia of the pulmonary veins (In conventional group)
Ablation time	24weeks	Time from to Ablation
Cost Effectiveness	24weeks	—
Survival Rate	24weeks	—
Complications	24weeks	* procedure and device related adverse event requiring any intervention to prevent permanent medical intervention * Important complications are reported individually
Procedural Success	24weeks	Achievement of the procedure endpoint for each arrhythmia

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026