Imaging Cardiac Electrical Remodeling With Electrocardiogram Imaging (ECGI)
1 other identifier
observational
13
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2007
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
November 3, 2008
CompletedFirst Posted
Study publicly available on registry
November 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedJanuary 8, 2019
January 1, 2019
3.8 years
November 3, 2008
January 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ECGI Image
1 month after RV pacing
Eligibility Criteria
Patients of a pacemaker clinic
You may qualify if:
- Implanted dual chamber pacemaker for sick sinus syndrome with no history of complete heart block.
You may not qualify if:
- Persistent atrial fibrillation that is not suppressed by medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University School of Medicine
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell N Faddis, MD PhD
Washington University School of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2008
First Posted
November 5, 2008
Study Start
November 1, 2007
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
January 8, 2019
Record last verified: 2019-01