NCT01394965

Brief Summary

The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging methodology for localizing and imaging cardiac electrical activity from body surface electrocardiographic recordings in patients with ventricular tachycardia (VT). Using non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

July 7, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
2.2 years until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

Same day

First QC Date

July 7, 2011

Last Update Submit

October 18, 2013

Conditions

Cardiac Arrhythmia

Keywords

ECGMappingecg mappingarrythmias

Outcome Measures

Primary Outcomes (1)

  • Results of ECG Mapping

    Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals

    1 year

Study Arms (1)

ECG Mapping

NO INTERVENTION
Procedure: ECG electrodes

Interventions

ECG electrodesPROCEDURE

Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.

Also known as: Electrode strips, Electrode patches
ECG Mapping

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Any patient undergoing ablation.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel Asirvatham, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 7, 2011

First Posted

July 15, 2011

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

US(1)