Ventricular Tachycardia
Conditions
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.
Interventions
DRUG[C-11] Meta-hydroxyephedrine radioactive tracer (MHED)
this tracer detects the distribution of sympathetic nerve fibers in the left ventricle
Sponsors
Biosense Webster, Inc.
Washington University School of Medicine
Khaled Awad, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation Between PET Data and Electroanatomic Data | 1 week |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm - PET/CT Imaging With [C-11] MHED Patients receiving PET/CT imaging with \[C-11\] MHED tracer | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | MHED tracer not available | 5 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Single Arm - PET/CT Imaging With [C-11] MHED |
|---|---|
| Age, Continuous | 65.3 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Correlation Between PET Data and Electroanatomic Data
Time frame: 1 week
Population: No outcomes were measured as no patients had complete data.