Electrocardiographic Mapping and Imaging
Primary Purpose
Cardiac Arrhythmia
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
ECG electrodes
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrhythmia focused on measuring ECG, Mapping, ecg mapping, arrythmias
Eligibility Criteria
Any patient undergoing ablation.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
ECG Mapping
Arm Description
Outcomes
Primary Outcome Measures
Results of ECG Mapping
Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals
Secondary Outcome Measures
Full Information
NCT ID
NCT01394965
First Posted
July 7, 2011
Last Updated
October 18, 2013
Sponsor
Mayo Clinic
Collaborators
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01394965
Brief Title
Electrocardiographic Mapping and Imaging
Official Title
Electrocardiographic Mapping and Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Withdrawn
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrhythmia
Keywords
ECG, Mapping, ecg mapping, arrythmias
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECG Mapping
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
ECG electrodes
Other Intervention Name(s)
Electrode strips, Electrode patches
Intervention Description
Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.
Primary Outcome Measure Information:
Title
Results of ECG Mapping
Description
Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Any patient undergoing ablation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Asirvatham, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Electrocardiographic Mapping and Imaging
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