Electrocardiographic Mapping and Imaging

Cardiac Arrhythmia Clinical Trial

Official title:

Electrocardiographic Mapping and Imaging

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01394965
• Other study ID #: 10-004825
• Status: Withdrawn
• Phase: Phase 0
• First received: July 7, 2011
• Last updated: October 18, 2013
• Start date: October 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older
• Eligibility: Any patient undergoing ablation.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiac Arrhythmia

Intervention

Procedure:
• ECG electrodes
Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of ECG Mapping	Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals	1 year	No