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

November 13, 2024 updated by: Khaled Awad, MD

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm - PET/CT Imaging With [C-11] MHED
Single Arm - positron emission tomography/computed tomography imaging with [C-11] meta-Hydroxyephedrine tracer
Drug: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
this tracer detects the distribution of sympathetic nerve fibers in the left ventricle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation Between PET Data and Electroanatomic Data
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khaled Awad, MD

Collaborators

Washington University School of Medicine
Biosense Webster, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

November 9, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimated)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F141013002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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