Electrocardiographic Mapping and Imaging

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Samuel J. Asirvatham, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01394965
First received: July 7, 2011
Last updated: October 18, 2013
Last verified: October 2013

July 7, 2011
October 18, 2013
October 2013
October 2013   (final data collection date for primary outcome measure)
Results of ECG Mapping [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals
Same as current
Complete list of historical versions of study NCT01394965 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Electrocardiographic Mapping and Imaging
Electrocardiographic Mapping and Imaging

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.

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.

Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Cardiac Arrhythmia
Procedure: ECG electrodes
Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.
Other Names:
  • Electrode strips
  • Electrode patches
No Intervention: ECG Mapping
Intervention: Procedure: ECG electrodes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2013
October 2013   (final data collection date for primary outcome measure)

Any patient undergoing ablation.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01394965
10-004825
No
Samuel J. Asirvatham, Mayo Clinic
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Samuel Asirvatham, MD Mayo Clinic
Mayo Clinic
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP