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Trial record 13 of 136 for:    Recruiting, Not yet recruiting, Available Studies | Tachycardia

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

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ClinicalTrials.gov Identifier: NCT02962076
Recruitment Status : Not yet recruiting
First Posted : November 11, 2016
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
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

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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

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

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

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Responsible Party: Khaled Awad, MD, MD, Mercy Research
ClinicalTrials.gov 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

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