Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy
Study Details
Study Description
Brief Summary
Presently, the left ventricular lead is placed in a similar position for all patients. It is not known whether placing this lead in different positions in the heart will make the heart pump better. In this study, the investigator will collect measurements of the heart's electrical activity during an Electrophysiology Study (EP study or EPS). The hope is that these measurements will provide the know how to develop an individualized left ventricular lead placement "prescription" for patients referred for left ventricular lead pacing.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Electrophysiology Study This is a single arm study, all study participants will be referred for an Electrophysiology Study |
Other: 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.
|
Outcome Measures
Primary Outcome Measures
- dP/dt measurements observed during pacing from different left ventricular regions [Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.]
During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ischemic cardiomyopathy
-
Intrinsic QRS duration >120 milliseconds
-
LV ejection fraction <40%
Exclusion Criteria:
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Persistent atrial tachyarrhythmia
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Active cardiac ischemia
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Cerebrovascular accident within 6 months
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Surgical or percutaneous cardiac revascularization procedure within 3 months
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Under 18 years of age
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Pregnant
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Participating in a clinical study that would preclude enrollment
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Unable to provide informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UPMC Presbyterian Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
- Medtronic
Investigators
- Principal Investigator: David S. Schwartzman, MD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Barold SS, Herwerg B. Pacing in heart failure: how many leads and where? Heart. 2008 Jan;94(1):10-2.
- 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. Review.
- Ellenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.
- Hayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.
- S. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine
- Schwartzman D, Schelbert E, Adelstein E, Gorcsan J, Soman P, Saba S. Image-guided cardiac resynchronization. Europace. 2010 Jun;12(6):877-80. doi: 10.1093/europace/euq103. Epub 2010 Apr 15.
- 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.
- PRO12070339