Working… Menu

Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02962076
Recruitment Status : Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : June 6, 2018
Washington University School of Medicine
Biosense Webster, Inc.
Information provided by (Responsible Party):
Khaled Awad, MD, Mercy Research

Brief Summary:
Imaging is to be performed prior to procedure using positron emission tomography/ computed tomography (PET/CT), after a special dye is injected. The scans are going to be merged with other cardiac scans when doing the ablation procedure to correlate anatomy with physiology.

Condition or disease Intervention/treatment Phase
Ventricular Tachycardia Radiation: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Radiation: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
    this tracer detects the distribution of sympathetic nerve fibers in the left ventricle

Primary Outcome Measures :
  1. correlation between PET data and electroanatomic data [ Time Frame: 1 week ]

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical indication for ventricular tachycardia (VT) ablation (at least one clinical episode of sustained VT) despite antiarrhythmic drug therapy, or if the patient does not wish to be on one
  • Ischemic or nonischemic cardiomyopathy
  • Sustained monomorphic VT

Exclusion Criteria:

  • Right ventricular VT
  • Polymorphic VT or ventricular fibrillation (VF) being the sole detected clinical arrhythmia
  • Patient is unable to sign informed consent
  • Recent myocardial infarction less than 30 days
  • Recent ablation for ventricular tachycardia less than 30 days
  • Patient is unwilling or unable to cooperate with the study
  • Prosthetic mitral or aortic valve
  • General contraindications to VT ablation, e.g., major contraindication to anticoagulation therapy, known presence of left ventricular thrombus, reversible causes of VT or VF
  • General contraindications to PET imaging, e.g., pregnancy or lactation
  • General contraindication to magnetic resonance imaging or to the administration of gadolinium.
  • Contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access

Layout table for additonal information
Responsible Party: Khaled Awad, MD, MD, Mercy Research Identifier: NCT02962076     History of Changes
Other Study ID Numbers: F141013002
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes