The Efficacy and Safety of CARTO 3D Mapping System Versus... | NCT00959205

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

NCT00959205

Sponsor

Korea University

Status

Unknown status

Last Update Posted

May 20, 2010Estimated

Enrollment

160Estimated

Phase

Phase 4

Conditions

Atrial Fibrillation

Interventions

CARTO 3D
Angiography

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Jun 2010Estimated

Completion Date

Feb 2011Estimated

First Submitted Date

Aug 13, 2009

First Submission Date that Met QC Criteria

Aug 13, 2009

First Posted Date

Aug 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2010

Last Update Posted Date

May 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Angiography	Active Comparator	Conventional fluoroscopically guided activation mapping	Device: Angiography
CARTO 3D	Experimental	CARTO (3D Electroanatomic imaging)	Device: CARTO 3D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CARTO 3D	Device	CARTO (3D Electroanatomic imaging)	CARTO 3D
Angiography

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Ablation time	Time from to Ablation	24weeks
Procedural Success	Achievement of the procedure endpoint for each arrhythmia	24weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with AF or substrate-dependent VT

Exclusion Criteria:

administering with anticoagulants

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kim Young-Hoon, MD, PhD	Korea medical center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Korea medical center		Seoul		136-705	South Korea
Asan Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000792	Angiography

Ancestor Terms

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided