Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy
NCT ID: NCT01825239
Last Updated: 2015-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-04-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Electrophysiology Study
This is a single arm study, all study participants will be referred for an Electrophysiology Study
Collection of measurements during LV pacing during electrophysiology study
During the electrophysiology study, measurements will be obtained while pacing from different left ventricular regions in context to scar as determined by SPECT-CT testing.
Interventions
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Collection of measurements during LV pacing during electrophysiology study
During the electrophysiology study, measurements will be obtained while pacing from different left ventricular regions in context to scar as determined by SPECT-CT testing.
Eligibility Criteria
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Inclusion Criteria
* Intrinsic QRS duration \>120 milliseconds
* LV ejection fraction \<40%
Exclusion Criteria
* Active cardiac ischemia
* Cerebrovascular accident within 6 months
* Surgical or percutaneous cardiac revascularization procedure within 3 months
* Under 18 years of age
* Pregnant
* Participating in a clinical study that would preclude enrollment
* Unable to provide informed consent
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
University of Pittsburgh
OTHER
Responsible Party
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David Schwartzman
Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh
Principal Investigators
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David S. Schwartzman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Countries
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References
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Hayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.
Ellenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.
Szydlo K, Wita K, Trusz-Gluza M, Urbanczyk D, Filipecki A, Orszulak W, Tabor Z, Krauze J, Kwasniewski W, Myszor J, Turski M, Kolasa J, Szczogiel J. Impact of left ventricular remodeling on ventricular repolarization and heart rate variability in patients after myocardial infarction treated with primary PCI: prospective 6 months follow-up. Ann Noninvasive Electrocardiol. 2008 Jan;13(1):8-13. doi: 10.1111/j.1542-474X.2007.00195.x.
Cohn JN, Ferrari R, Sharpe N. Cardiac remodeling--concepts and clinical implications: a consensus paper from an international forum on cardiac remodeling. Behalf of an International Forum on Cardiac Remodeling. J Am Coll Cardiol. 2000 Mar 1;35(3):569-82. doi: 10.1016/s0735-1097(99)00630-0.
S. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine
Adelstein EC, Saba S. Scar burden by myocardial perfusion imaging predicts echocardiographic response to cardiac resynchronization therapy in ischemic cardiomyopathy. Am Heart J. 2007 Jan;153(1):105-12. doi: 10.1016/j.ahj.2006.10.015.
Barold SS, Herwerg B. Pacing in heart failure: how many leads and where? Heart. 2008 Jan;94(1):10-2. doi: 10.1136/hrt.2007.119404. No abstract available.
Schwartzman D, et al. Image-guided left ventricular pacing. Europace 2010; 12: 877-81.
Other Identifiers
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PRO12070339
Identifier Type: -
Identifier Source: org_study_id
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