Virtual LV Lead Navigation in Patients With Ischemic Cardiomyopathy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
David Schwartzman, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01825239
First received: April 2, 2013
Last updated: December 10, 2013
Last verified: December 2013
  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: 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.


Estimated Enrollment: 25
Study Start Date: April 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01825239

Contacts
Contact: Dina Poole, RN 412-647-2931 pooledr@upmc.edu
Contact: Lynn Billisits, BSN 412-648-6024 billisitsl@upmc.edu

Locations
United States, Pennsylvania
UPMC Presbyterian Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dina Poole, RN    412-647-2931    pooledr@upmc.edu   
Contact: Lynn Billisits, BSN    412-648-6024    billisitsl@upmc.edu   
Principal Investigator: David S. Schwartzman, MD         
Sponsors and Collaborators
University of Pittsburgh
Medtronic
Investigators
Principal Investigator: David S. Schwartzman, MD University of Pittsburgh
  More Information

Publications:
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
Study First Received: April 2, 2013
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014