Clinical trial NCT01825239: Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy
Official title: Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiomyopathy
Ischemic Cardiomyopathy
Keywords: ischemic cardiomyopathy
cardiomyopathy
left ventricular lead
cardiac electrophysiologic studies
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2013-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* Ischemic cardiomyopathy
* Intrinsic QRS duration \>120 milliseconds
* LV ejection fraction \<40%

Exclusion Criteria:

* Persistent atrial tachyarrhythmia
* 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

Primary outcomes:
measure: dP/dt measurements observed during pacing from different left ventricular regions
timeFrame: Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: David S. Schwartzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.
citation: Ellenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.
citation: 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.
citation: 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.
citation: S. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine
citation: 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.
citation: 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.
citation: Schwartzman D, et al. Image-guided left ventricular pacing. Europace 2010; 12: 877-81.