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Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

This study has been withdrawn prior to enrollment.
(Problems with execution)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01825239
First Posted: April 5, 2013
Last Update Posted: August 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
David Schwartzman, University of Pittsburgh
  Purpose
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
Cardiomyopathy Ischemic Cardiomyopathy Other: Collection of measurements during LV pacing during electrophysiology study

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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 David Schwartzman, 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. ]
    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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01825239


Locations
United States, Pennsylvania
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
  More Information

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

Responsible Party: David Schwartzman, Professor of Medicine, Cardiac Electrophysiology, University of Pittsburgh, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01825239     History of Changes
Other Study ID Numbers: PRO12070339
First Submitted: April 2, 2013
First Posted: April 5, 2013
Last Update Posted: August 7, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases


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