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

NCT ID: NCT02962076

Last Updated: 2024-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-21

Study Completion Date

2024-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

this tracer detects the distribution of sympathetic nerve fibers in the left ventricle

Interventions

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

this tracer detects the distribution of sympathetic nerve fibers in the left ventricle

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosense Webster, Inc.

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

Khaled Awad, MD

OTHER

Sponsor Role lead

Responsible Party

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Khaled Awad, MD

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mercy Hospital St. Louis

St Louis, Missouri, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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F141013002

Identifier Type: -

Identifier Source: org_study_id