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

Sponsor
Mercy Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT02962076
Collaborator
Washington University School of Medicine (Other), Biosense Webster, Inc. (Industry)
15
Enrollment
1
Location
18.3
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
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
Actual Study Start Date :
Sep 21, 2020
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Outcome Measures

Primary Outcome Measures

  1. correlation between PET data and electroanatomic data [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 89 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mercy Hospital St. Louis Saint Louis Missouri United States 63141

Sponsors and Collaborators

  • Mercy Research
  • Washington University School of Medicine
  • Biosense Webster, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Khaled Awad, MD, MD, Mercy Research
ClinicalTrials.gov Identifier:
NCT02962076
Other Study ID Numbers:
  • F141013002
First Posted:
Nov 11, 2016
Last Update Posted:
Aug 16, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular

Study Results

No Results Posted as of Aug 16, 2021