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

Primary Purpose

Ventricular Tachycardia

Status
Enrolling by invitation
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
[C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
Sponsored by
Mercy Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mercy Hospital St. Louis

Outcomes

Primary Outcome Measures

correlation between PET data and electroanatomic data

Secondary Outcome Measures

Full Information

First Posted
November 9, 2016
Last Updated
August 17, 2023
Sponsor
Mercy Research
Collaborators
Washington University School of Medicine, Biosense Webster, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02962076
Brief Title
Study of Cardiac PET/CT Imaging to Guide Ablation Treatment of Ventricular Tachycardia
Official Title
Cardiac Positron Emission Tomography for Detection of Cardiac Sympathetic Dysinnervation to Guide Ablation of Ventricular Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mercy Research
Collaborators
Washington University School of Medicine, Biosense Webster, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
[C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
Intervention Description
this tracer detects the distribution of sympathetic nerve fibers in the left ventricle
Primary Outcome Measure Information:
Title
correlation between PET data and electroanatomic data
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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. Contraindication to the placement of hemodynamic support devices, i.e. the presence of mechanical valves or lack of adequate vascular access
Facility Information:
Facility Name
Mercy Hospital St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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