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Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

Primary Purpose

Cardiomyopathy, Ischemic Cardiomyopathy

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collection of measurements during LV pacing during electrophysiology study
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiomyopathy focused on measuring ischemic cardiomyopathy, cardiomyopathy, left ventricular lead, cardiac electrophysiologic studies

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UPMC Presbyterian Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Electrophysiology Study

Arm Description

This is a single arm study, all study participants will be referred for an Electrophysiology Study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2013
Last Updated
August 5, 2015
Sponsor
University of Pittsburgh
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01825239
Brief Title
Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy
Official Title
Virtual Left Ventricular Lead Navigation in Patients With Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Problems with execution
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy, Ischemic Cardiomyopathy
Keywords
ischemic cardiomyopathy, cardiomyopathy, left ventricular lead, cardiac electrophysiologic studies

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrophysiology Study
Arm Type
Other
Arm Description
This is a single arm study, all study participants will be referred for an Electrophysiology Study
Intervention Type
Other
Intervention Name(s)
Collection of measurements during LV pacing during electrophysiology study
Intervention Description
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.
Primary Outcome Measure Information:
Title
dP/dt measurements observed during pacing from different left ventricular regions
Description
During the electrophysiology study, the dP/dt measurements will be observed during pacing from different left ventricular regions.
Time Frame
Measurements will be observed at the time of the electrophysiology study (EPS) at enrollment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S. Schwartzman, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Presbyterian Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Hayes, D.L, et al. Resynchronization and Defibrillation for Heart Failure: A Practical Approach. UK: Blackwell Publishing, 2004.
Results Reference
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Citation
Ellenbogen K.A., et al. Device Therapy for Congestive Heart Failure. Pennsylvania: Saunders, 2004.
Results Reference
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PubMed Identifier
18234001
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.
Results Reference
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PubMed Identifier
10716457
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.
Results Reference
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Citation
S. Goel. Pacing For Patients With Congestive Heart Failure and Dilated Cardiomyopathy www.dcmsonline.org February, 2002/ Jacksonville Medicine
Results Reference
background
PubMed Identifier
17174647
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.
Results Reference
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PubMed Identifier
18083947
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.
Results Reference
background
Citation
Schwartzman D, et al. Image-guided left ventricular pacing. Europace 2010; 12: 877-81.
Results Reference
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Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

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