Clinical trial NCT01250912: Imaging With a Radio Tracer to Guide VT Ablations
Official title: Three Dimension Neuron Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Ventricular Tachycardia Ablations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Arrhythmia
Keywords: Ablation
Arrythmia
Imaging
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2010-12-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Some patients are at risk for life-threatening fast heart rates. These can frequently be treated by using a catheter inside the heart to burn away the cells that create the fast heart rates. The purpose of this study is to image the nerves inside the heart of those patients. The investigators want to find out if abnormalities in the nervous system in the heart can help the physician to find the area that needs to be burnt away.

Detailed description: Ventricular tachycardia is the next frontier in cardiology. Patients that have scar in the heart (for example after heart attacks) are at an increased risk of developing ventricular tachycardia. In these patients ventricular tachycardia represents an electrical wave front that circulates in the heart muscle using the scar in the heart. An increasing number of patients with ventricular tachycardia require cauterization (burning away) of the tissue to treat this life-threatening condition. The goal of this cauterization or ablation is to destroy "highways of surviving tissue" inside the scar, that allow ventricular tachycardia to exist. However, this can be very lengthy procedure (\>5 hours) that has only a moderate success in the long run. Therefore, new treatment approaches are needed to make this procedure better.

The purpose of this study is to assess if radio tracers showing the nerve distribution in the heart (cardiac innervation) can be used in addition to the current technology ("voltage mapping") to identify the area that needs to be ablated (burnt away) to treat life-threatening fast heart rates (ventricular tachycardia)

Certain patterns of nerve distribution in the heart (sympathetic cardiac innervation) have been shown to predict outcome for different heart diseases, like heart transplant, coronary artery disease, heart failure, arrhythmias. One substance that allows visualization of the cardiac innervation is 123I-metaiodobenzylguanidine (123I-MIBG), which could provide additional information to understand and treat ventricular tachycardia.

Eligibility criteria: Inclusion Criteria:

* Patients with ventricular arrhythmias requiring VT Ablation
* Patients must be 18 years of age or older
* Patient must be able to sign consent form
* Patient must be willing to come back for the 6 month visit for additional study procedures

Exclusion Criteria:

* Patient under 18 years old
* Inability to sign consent
* Pregnant Women

Primary outcomes:
measure: Comparison of the Percentage of Patients With Scar in Each Segment as Determined by MIBG SPECT Versus Electroanatomic at Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Median Segmental MIBG Uptake at Baseline
timeFrame: Baseline
measure: Median Segmental MIBG Uptake at 6 Months After Ablation
timeFrame: 6 months after ablation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center, EP Lab, Rm. N3W77
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Timm R Dickfeld, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tian J, Smith MF, Jeudy J, Dickfeld T. Multimodality fusion imaging using delayed-enhanced cardiac magnetic resonance imaging, computed tomography, positron emission tomography, and real-time intracardiac echocardiography to guide ventricular tachycardia ablation in implantable cardioverter-defibrillator patients. Heart Rhythm. 2009 Jun;6(6):825-8. doi: 10.1016/j.hrthm.2009.02.032. Epub 2009 Feb 24. No abstract available.
citation: Tian J, Smith MF, Chinnadurai P, Dilsizian V, Turgeman A, Abbo A, Gajera K, Xu C, Plotnick D, Peters R, Saba M, Shorofsky S, Dickfeld T. Clinical application of PET/CT fusion imaging for three-dimensional myocardial scar and left ventricular anatomy during ventricular tachycardia ablation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):567-604. doi: 10.1111/j.1540-8167.2008.01377.x.
citation: Dickfeld T, Kocher C. The role of integrated PET-CT scar maps for guiding ventricular tachycardia ablations. Curr Cardiol Rep. 2008 Mar;10(2):149-57. doi: 10.1007/s11886-008-0025-1.
citation: Klein T, Abdulghani M, Smith M, Huang R, Asoglu R, Remo BF, Turgeman A, Mesubi O, Sidhu S, Synowski S, Saliaris A, See V, Shorofsky S, Chen W, Dilsizian V, Dickfeld T. Three-dimensional 123I-meta-iodobenzylguanidine cardiac innervation maps to assess substrate and successful ablation sites for ventricular tachycardia: feasibility study for a novel paradigm of innervation imaging. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):583-91. doi: 10.1161/CIRCEP.114.002105. Epub 2015 Feb 23.