Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

NCT01825239 | Withdrawn

• 1 other identifier: PRO12070339
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiomyopathy; Ischemic Cardiomyopathy

Keywords

ischemic cardiomyopathy; cardiomyopathy; left ventricular lead; cardiac electrophysiologic studies

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Electrophysiology Study

OTHER

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

Interventions

Collection of measurements during LV pacing during electrophysiology study OTHER

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.

Electrophysiology Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Medtronic: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (8)

• Hayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.

  BACKGROUND

• Ellenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.

  BACKGROUND

• 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.

  PMID: 18234001 BACKGROUND

• 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.

  PMID: 10716457 BACKGROUND

• S. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine

  BACKGROUND

• 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.

  PMID: 17174647 BACKGROUND

• 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.

  PMID: 18083947 BACKGROUND

• Schwartzman D, et al. Image-guided left ventricular pacing. Europace 2010; 12: 877-81.

  BACKGROUND

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• David S. Schwartzman, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh

Study Record Dates

• First Submitted: April 2, 2013
• First Posted: April 5, 2013
• Study Start: April 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: August 7, 2015

Record last verified: 2015-08

Locations

US (1)