- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394965
Electrocardiographic Mapping and Imaging
Study Overview
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.
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: ECG Mapping
|
Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Results of ECG Mapping
Time Frame: 1 year
|
Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Samuel Asirvatham, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-004825
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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