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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Cardiac Arrhythmia
Procedure: ECG electrodes
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Electrocardiographic Mapping and Imaging

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: October 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: ECG Mapping 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Any patient undergoing ablation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394965

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Samuel Asirvatham, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Samuel J. Asirvatham, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01394965     History of Changes
Other Study ID Numbers: 10-004825
Study First Received: July 7, 2011
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
ECG
Mapping
ecg mapping
arrythmias

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014