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Use of MIBG Scan Images in PVC Ablations (PVC-MIBG)

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ClinicalTrials.gov Identifier: NCT02279030
Recruitment Status : Recruiting
First Posted : October 30, 2014
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Timm-Michael Dickfeld, University of Maryland

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.

Condition or disease Intervention/treatment
Premature Ventricular Contractions Other: MIBG nuclear scan

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 population.1 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 PVCs.2 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 approach.9 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 ablation.8 Improvement of the overall LV EF ranged from 13%-23% after PVC ablation.5,8,10

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, e.g. 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 automatic/triggered 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 Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Three Dimensional Neuro-cardiac Imaging Using 123I-metaiodobenzylguanidine Single Photon Emission Computed Tomography to Guide Premature Ventricular Contractions Ablations
Study Start Date : June 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans


Intervention Details:
  • Other: MIBG nuclear scan
    To have scan to help define pathways for PVC ablations.
    Other Name: PVC ablations


Primary Outcome Measures :
  1. Utilization of MIBG imaging for PVC ablations [ Time Frame: 2 years ]
    To determine if MIBG imaging provides decreased PVC ablation time

  2. Decrease PVC occurrence [ Time Frame: 2 years ]
    Does MIBG imaging allow for treatment that provides improved outcomes in decreasing PVCs

  3. Increase in Motility [ Time Frame: 2 years ]
    Do MIBG follow-ups demonstrate an improvement in cardiac motility



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients requiring PVC ablation
Criteria

Inclusion Criteria:

  • Scheduled for PVC ablation

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279030


Contacts
Contact: Diandra Browne 410-328-7801 dibrown@som.umaryland.edu

Locations
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Timm Dickfeld, PhD    410-328-6056    tdickfel@som.umaryland.edu   
Contact: Diandra Browne    410-328-7801    dibrown@som.umaryland.edu   
Principal Investigator: Timm Dickfeld, PhD         
Sponsors and Collaborators
University of Maryland
GE Healthcare

Responsible Party: Timm-Michael Dickfeld, CARDIAC ELECTROPHYSIOLOGY PHYSICIAN, University of Maryland
ClinicalTrials.gov Identifier: NCT02279030     History of Changes
Other Study ID Numbers: HP-00062156
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Timm-Michael Dickfeld, University of Maryland:
ablation

Additional relevant MeSH terms:
Premature Birth
Ventricular Premature Complexes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Cardiac Complexes, Premature
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes