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Clinical Trials/NCT02962076
NCT02962076
Terminated
Early Phase 1

Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia

Khaled Awad, MD1 site in 1 country11 target enrollmentSeptember 21, 2020

Overview

Phase
Early Phase 1
Intervention
[C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
Conditions
Ventricular Tachycardia
Sponsor
Khaled Awad, MD
Enrollment
11
Locations
1
Primary Endpoint
Correlation Between PET Data and Electroanatomic Data
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 21, 2020
End Date
October 31, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Khaled Awad, MD

MD

Mercy Research

Eligibility 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.

Arms & Interventions

Single Arm - PET/CT Imaging With [C-11] MHED

Single Arm - positron emission tomography/computed tomography imaging with \[C-11\] meta-Hydroxyephedrine tracer

Intervention: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)

Outcomes

Primary Outcomes

Correlation Between PET Data and Electroanatomic Data

Time Frame: 1 week

Study Sites (1)

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