Measuring Electrical Resistance of Different Tissues on the Outer Surface of the Heart

This study has been terminated.
(Unforeseen difficulty identifying and enrolling eligible subjects)
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00291174
First received: February 10, 2006
Last updated: September 12, 2012
Last verified: June 2012
  Purpose

This is a research study to evaluate the electrical properties of heart tissue. The purpose of this study is to determine the impedance (electrical resistance) of different tissues on the outer surface of the heart. This may be important for distinguishing scarred heart muscle from fat that can be seen on the surface of the heart. This information may eventually be utilized in patients that undergo a procedure (called catheter ablation) for the treatment of life-threatening heart rhythms. Investigators expect a detectable difference between the impedance of normal and infarcted myocardium (approximately 50 ohms).


Condition
Cardiomyopathies
Ventricular Dysfunction
Myocardial Infarction
Arrhythmia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impedance Measurement of Epicardial Substrate for Ventricular Arrhythmias: Case Control Series of Patients With and Without Myocardial Scarring

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Enrollment: 8
Study Start Date: April 2006
Study Completion Date: January 2008
Detailed Description:

The treatment of cardiac arrhythmias with endocardial catheter ablation has evolved rapidly over the past few decades. At the time of this writing, the ablation of almost all atrial and ventricular arrhythmias has been described in the literature. Multiple energy modalities (e.g. radiofrequency, cryotherapy) and approaches (e.g. retrograde aortic, transseptal puncture) have been described, yet ablation of some rhythms is not as successful as others.

The realization that ventricular tachycardia (VT) in the setting of Chagas Disease can originate in the epicardium has lead to the development of a percutaneous, transthoracic epicardial approach to mapping and ablation of this arrhythmia. This approach has now been applied to patients with VT in the setting of ischemic and nonischemic heart disease at many centers throughout the world. Traditional mapping technologies are utilized on the epicardium to define scarred heart tissue and locate the VT circuit.

It is well known that human hearts display a variable amount of fat overlying the epicardium. Not only is the coronary vasculature embedded in a layer of adipose tissue, but the rest of the heart may have areas of epicardial fat. As fat is an insulator and does not generate or easily conduct electrical activity, current mapping techniques may classify epicardial fat incorrectly as myocardial scar. This may have important effects on the ability to diagnose and treat arrhythmias with epicardial ablation.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients undergoing elective cardiac surgery for coronary artery disease

Criteria

Inclusion Criteria:

  • All adult patients undergoing elective cardiac surgery for coronary artery disease (with or without normal heart function) or valvular disease (with normal heart function) at the Hospital of the University of Pennsylvania under the direction of Y. Joseph Woo MD will be eligible.

Exclusion Criteria:

  • Patients undergoing emergent surgery and patients with idiopathic cardiomyopathy, infiltrative cardiomyopathies and hypertrophic cardiomyopathies will be excluded.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00291174

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Biosense Webster, Inc.
Investigators
Principal Investigator: David J. Callans, MD University of Pennsylvania, Dept of Medicine, Cardiology Division
  More Information

Publications:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00291174     History of Changes
Other Study ID Numbers: 803272
Study First Received: February 10, 2006
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Ventricular Arrhythmia
Myocardial Infarction
Ventricular Dysfunction
Coronary Artery Disease
Structural Heart Disease
Arrhythmia
Cardiomyopathies

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Infarction
Myocardial Infarction
Ventricular Dysfunction
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014