Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

Cardiomyopathy Clinical Trial

Official title:

Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01825239
• Other study ID #: PRO12070339
• Status: Withdrawn
• Phase: N/A
• First received: April 2, 2013
• Last updated: August 5, 2015
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Ischemia
• Ischemic Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC Presbyterian Hospital	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

Barold SS, Herwerg B. Pacing in heart failure: how many leads and where? Heart. 2008 Jan;94(1):10-2. — View 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. Review. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dP/dt measurements observed during pacing from different left ventricular regions	During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions.	Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.	No