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NCT02962076 Clinical Trial

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

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT02962076
Other study ID # F141013002
Secondary ID
Status Enrolling by invitation
Phase Early Phase 1
First received
Last updated
Start date September 21, 2020
Est. completion date December 31, 2025

Study information
Verified date April 2024
Source Mercy Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 15
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• [C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
this tracer detects the distribution of sympathetic nerve fibers in the left ventricle

Locations
Country Name City State
United States Mercy Hospital St. Louis Saint Louis Missouri

Sponsors (3)
Lead Sponsor Collaborator
Mercy Research Biosense Webster, Inc., Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary correlation between PET data and electroanatomic data 1 week
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