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

NCT02962076 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: F141013002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia

Outcome Measures

Primary Outcomes (1)

• Correlation Between PET Data and Electroanatomic Data

  1 week

Study Arms (1)

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

EXPERIMENTAL

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

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khaled Awad, MD: lead
• Biosense Webster, Inc.: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

Mercy Hospital St. Louis

St Louis, Missouri, 63141, United States

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

3-alpha-Hydroxysteroid Dehydrogenase (B-Specific)

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

3-Hydroxysteroid Dehydrogenases; Hydroxysteroid Dehydrogenases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases

Limitations and Caveats

Overall study data is limited given the study was terminated before reaching the enrollment goal.

Results Point of Contact

• Title: Michelle Bryant, MPH
• Organization: Mercy Research

michelle.bryant@mercy.net

314-251-8827

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 9, 2016
• First Posted: November 11, 2016
• Study Start: September 21, 2020
• Primary Completion: March 1, 2023
• Study Completion: October 31, 2024
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)