NCT00959205

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P25-P50 for phase_4 atrial-fibrillation

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

May 20, 2010

Status Verified

August 1, 2009

Enrollment Period

11 months

First QC Date

August 13, 2009

Last Update Submit

May 19, 2010

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

  • Fluoroscopic time

    Total duration of procedure using fluoroscopy on , in minute

    24weeks

  • Procedural duration

    Time from after puncture to catheter remover

    24weeks

Secondary Outcomes (8)

  • Ablation time

    24weeks

  • Procedural Success

    24weeks

  • Clinical Success

    24weeks

  • Radiation dose

    24weeks

  • Morphology of ablation

    24weeks

  • +3 more secondary outcomes

Study Arms (2)

Angiography

ACTIVE COMPARATOR

Conventional fluoroscopically guided activation mapping

Device: Angiography

CARTO 3D

EXPERIMENTAL

CARTO (3D Electroanatomic imaging)

Device: CARTO 3D

Interventions

CARTO 3DDEVICE

CARTO (3D Electroanatomic imaging)

CARTO 3D
AngiographyDEVICE

Conventional fluoroscopically guided activation mapping

Also known as: Celsius
Angiography

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with AF or substrate-dependent VT

You may not qualify if:

  • administering with anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Korea medical center

Seoul, 136-705, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital/Internal Medicine

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Angiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Cardiovascular

Study Officials

  • Kim Young-Hoon, MD, PhD

    Korea medical center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

February 1, 2011

Last Updated

May 20, 2010

Record last verified: 2009-08

Locations

KR(5)