Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)

January 4, 2019 updated by: Washington University School of Medicine

Imaging Cardiac Electrical Remodeling With ECGI

A consequence of chronic RV pacing is a process of electrical remodeling that alters myocardial repolarization to reflect the altered depolarization induced by the RV lead. When RV pacing is discontinued, the altered repolarization persists for several weeks. This phenomena is traditionally described as "T-wave memory" based upon the 12-lead ECG appearance of inverted T-Waves. The investigators are using the ECGI technique to produce three dimensional electroanatomical images of this phenomena in patients with dual chamber pacemakers. Echocardiography will also be used to image the mechanical effects of RV pacing and T-wave memory. The images will show the spatial distribution of altered repolarization and allow us to correlate any mechanical consequences of this phenomena that may exist.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

13

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of a pacemaker clinic

Description

Inclusion Criteria:

  • Implanted dual chamber pacemaker for sick sinus syndrome with no history of complete heart block.

Exclusion Criteria:

  • Persistent atrial fibrillation that is not suppressed by medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ECGI Image
Time Frame: 1 month after RV pacing
1 month after RV pacing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Mitchell N Faddis, MD PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

November 3, 2008

First Submitted That Met QC Criteria

November 4, 2008

First Posted (Estimate)

November 5, 2008

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

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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