Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

This study has been withdrawn prior to enrollment.
(Problems with execution)
Information provided by (Responsible Party):
David Schwartzman, University of Pittsburgh Identifier:
First received: April 2, 2013
Last updated: August 5, 2015
Last verified: August 2015
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 Intervention
Ischemic Cardiomyopathy
Other: Collection of measurements during LV pacing during electrophysiology study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • dP/dt measurements observed during pacing from different left ventricular regions [ Time Frame: Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment. ] [ Designated as safety issue: No ]
    During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions.

Enrollment: 0
Study Start Date: April 2014
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01825239

United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Principal Investigator: David S. Schwartzman, MD University of Pittsburgh
  More Information

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

Responsible Party: David Schwartzman, Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh, University of Pittsburgh Identifier: NCT01825239     History of Changes
Other Study ID Numbers: PRO12070339
Study First Received: April 2, 2013
Last Updated: August 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
ischemic cardiomyopathy
left ventricular lead
cardiac electrophysiologic studies

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Pathologic Processes processed this record on November 27, 2015