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WithdrawnNCT01394965Updated Oct 21, 2013

Electrocardiographic Mapping and Imaging

An Early Phase 1 interventional study of ECG electrodes in Cardiac Arrhythmia, sponsored by Mayo Clinic. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-21.

Sponsored by Mayo Clinic · Early Phase 1, Interventional, and Diagnostic

Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Specific Aims

  1. Use non-invasive cardiac electric imaging to provide information as to the sites of origin of arrhythmias and sequence of cardiac activation and repolarization.

Methods and Procedures Approximately 8 patients with recorded Premature Ventricular Contractions (PVC), Wolff-Parkinson-White (WPW) or other ventricular tachycardia cases which need Ensite/Carto endocardial mapping and radiofrequency ablation treatment will be enrolled.

One day before catheterization and ablation, patients will undergo approximately 30 minutes of Body Surface Potential Mapping (BSPM) recordings with about 200 surface electrodes arranged in 20 strips, attached on his/her front and back. BSPMs will be recorded in the baseline resting rhythm.

On the day of ablation, before catheterization in the surgical room, the BSPM recording procedure will be carried out with the patient using the same technique used during the first BSPM study.

Clinical endocardial mapping data may also be obtained concurrently with BSPM recordings before the ablation procedure.

Another BSPM recording will be made 30-60 minutes after successful ablation with the patient still in normal sinus rhythm if possible. Patients will be followed up 1 month after ablation with the same method of BSPM recorded at the baseline resting rhythm.

02

Conditions studied

  • Cardiac Arrhythmia

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Keywords

  • ECG
  • Mapping
  • ecg mapping
  • arrythmias
03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.

Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Any patient undergoing ablation.

05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
0 participants (actual)

Study arms

  • No intervention
    ECG Mapping

    Procedure: ECG electrodes

Interventions

  • ProcedureECG electrodes

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

    Also known as: Electrode strips, Electrode patches

06

What researchers measure

Primary outcomes

  1. Results of ECG Mapping

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

    Time frame: 1 year

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01394965
Lead sponsor
Mayo Clinic
Collaborators
University of Minnesota
Responsible party
Samuel J. Asirvatham (PI, Mayo Clinic) — Principal investigator
First posted
Jul 15, 2011
Start date
Oct 2013
Primary completion
Oct 2013
Completion
Oct 2013
Last update
Oct 21, 2013

Study contacts

Samuel Asirvatham, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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