Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02279030
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2014-10-20
Brief Title:
Use of MIBG Scan Images in PVC Ablations
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Three Dimensional Neuro-cardiac Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Premature Ventricular Contractions Ablations
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PVC-MIBG
Brief Summary:
The purpose of this study is to assess if Single Photon Emission Computed Tomography SPECT demonstrating cardiac innervation can be integrated into current electrophysiology voltage mapping system and provide improved guidance for ablation of PVCs
Detailed Description:
Premature ventricular contractions PVC are the most common arrhythmia to be observed in the absence of structural heart disease and frequent PVCs are estimated to occur in 1-4 of the general population1 Idiopathic PVCs are usually associated with a benign course from the standpoint of arrhythmic death but often result in significant symptoms for the patient such as palpitations dizziness pre-syncope and rarely syncope More recently a new concept of PVC- mediated cardiomyopathy has emerged that is reversible with suppression of the PVCs2 Both of those patient populations are currently targeted with PVC suppressive therapy which often involves as the first step using medical therapy such as a beta blocker calcium channel blocker or an antiarrhythmic If those fail or if the patients wants to avoid medical therapy an ablation to eliminate the abnormal myocardial tissue that is the origin of the PVCs is often performed
Radiofrequency ablation RFA for PVCs has been performed for several decades and has a well-defined safety and effectiveness profile in patients with symptomatic frequent ventricular ectopic beats and PVC-induced cardiomyopathy Successful PVC suppression 80 of RV and LV PVCs has been reported to be as high as 80 using an ablation approach9 Studies found improvements in patient symptoms with elimination of PVCs In LV dysfunction following ablation demonstrated a significant inverse correlation between EF and PVC burden before ablation and a significant post procedural improvement in ejection fraction EF in 82 of patients who had abnormal systolic function before ablation8 Improvement of the overall LV EF ranged from 13-23 after PVC ablation5810
Autonomic innervation of the heart plays a major role in the normal regulation of myocardial function heart rate and coronary blood flow Abnormal sympathetic cardiac innervation has been shown to have prognostic value for different heart diseases eg heart transplant coronary artery disease heart failure arrhythmias etc Importantly there is a clear association with an increased cardiac morbidity and mortality in heart diseases Patients with myocardial infarction as well as patients with heart failure exhibit well recognized abnormalities in autonomic tone PVCs especially in the setting of preserved EF normal heart patients have frequently an automatictriggered mechanism which is influenced by the cardiac innervation
Decreased reuptake by impaired myocardial presynaptic nerve terminals results in a buildup of these catecholamines in the synaptic cleft This leads to a downregulation of postsynaptic beta-adrenergic receptors with resultant worsening cardiomyopathy and increased arrhythmogenesis
Cardiac sympathetic innervation can be directly imaged with commonly used nuclear radioisotope 123I-meta-iodobenzylguanidine 123I-mIBG As a norepinephrine analogue 123I-mIBG is similarly released into the synaptic cleft in response to sympathetic input by presynaptic nerve terminals 123I-metaiodobenzylguanidine 123I-MIBG allows visualization of the cardiac innervation which could provide additional information to understand the origin prognosis and pathophysiology of PVCs and guide potential ablation procedures
Radiofrequency ablation RFA for PVCs has been performed for several decades and has a well-defined safety and effectiveness profile in patients with symptomatic frequent ventricular ectopic beats and PVC-induced cardiomyopathy Successful PVC suppression 80 of RV and LV PVCs has been reported to be as high as 80 using an ablation approach9 Studies found improvements in patient symptoms with elimination of PVCs In LV dysfunction following ablation demonstrated a significant inverse correlation between EF and PVC burden before ablation and a significant post procedural improvement in ejection fraction EF in 82 of patients who had abnormal systolic function before ablation8 Improvement of the overall LV EF ranged from 13-23 after PVC ablation5810
Autonomic innervation of the heart plays a major role in the normal regulation of myocardial function heart rate and coronary blood flow Abnormal sympathetic cardiac innervation has been shown to have prognostic value for different heart diseases eg heart transplant coronary artery disease heart failure arrhythmias etc Importantly there is a clear association with an increased cardiac morbidity and mortality in heart diseases Patients with myocardial infarction as well as patients with heart failure exhibit well recognized abnormalities in autonomic tone PVCs especially in the setting of preserved EF normal heart patients have frequently an automatictriggered mechanism which is influenced by the cardiac innervation
Decreased reuptake by impaired myocardial presynaptic nerve terminals results in a buildup of these catecholamines in the synaptic cleft This leads to a downregulation of postsynaptic beta-adrenergic receptors with resultant worsening cardiomyopathy and increased arrhythmogenesis
Cardiac sympathetic innervation can be directly imaged with commonly used nuclear radioisotope 123I-meta-iodobenzylguanidine 123I-mIBG As a norepinephrine analogue 123I-mIBG is similarly released into the synaptic cleft in response to sympathetic input by presynaptic nerve terminals 123I-metaiodobenzylguanidine 123I-MIBG allows visualization of the cardiac innervation which could provide additional information to understand the origin prognosis and pathophysiology of PVCs and guide potential ablation procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None