An observational study in Cardiac Arrhythmias, Electroanatomic Mapping and Cardiac Ablation, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Beth Israel Deaconess Medical Center · Observational
The purpose of this study is to compare two different types of three-dimensional electroanatomic mapping systems used for the treatment of cardiac arrhythmias. The systems will be compared in regards to its ability to successfully map and ablate a clinical arrhythmia, as well as the time invested in this activity.
Despite the advancement in catheter ablation technology over the past decade, the essential step in therapy entails identification and accurate mapping of the arrhythmia mechanism and its anatomical substrate. These are performed with the assistance of mapping systems and catheters able to record high fidelity local electrical activity of the heart (electrogram, EGM) and display it in three-dimensional views. Current mapping systems are limited by slow and incomplete arrhythmia mapping, limiting successful therapies.
The Rhythmia™ Mapping System (Rhythmia), including its novel basket catheter (IntellaMap Orion™ High Resolution Mapping Catheter), is an FDA approved mapping system available for use during clinical, standard of care electrophysiology procedures at BIDMC. Its unique design allows improved mapping resolution of cardiac arrhythmias, particularly those with complex disease substrate, such as atrial and ventricular tachycardias. Specifically, the investigators plan to enroll patients undergoing electrophysiology study and ablation for atrial flutter/fibrillation, atrial tachycardia and ventricular tachycardia. The system was developed to provide high-resolution maps based on the rapid, automated acquisition of a very large number of low noise electrograms. This mapping system was designed to improve the speed and clinical outcomes over other systems that do not have this rapid automated acquisition capability.
The Rhythmia mapping system is FDA approved and will be made available for use in clinical procedures at BIDMC. Rhythmia will be installed in one of the three electrophysiology labs at BIDMC and the use of the system is at the discretion of the electrophysiologist performing the procedure. Thus, using or not using the Rhythmia system to guide arrhythmia mapping and ablation is not a deviation from the standard of care.
The goal of this registry study is to examine the clinical utility of the system to create accurate electroanatomical maps and validate the data acquired by comparing it with historical cohorts of electroanatomical signals and their corresponding maps created with the traditional Carto®3 electroanatomic mapping system (Biosense Webster, Inc).
Patients will only be approached for enrollment when the treating physician has elected to utilize the Rhythmia mapping system during the standard clinical procedure. The data acquired will be collected by a member of the research team in a clinical registry for offline analysis.
The aim/hypotheses tested by this study include:
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 20 is below the median of 200 across 414 observational studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
This study will enroll patients who present for standard of care catheter ablation procedures for atrial and ventricular arrhythmias.
Exclusion Criteria:
The study sample includes patients referred for three different types of cardiac arrhythmias, which will be the studied categories: 1) atrial flutter/fibrillation, 2) atrial tachycardia, 3) ventricular tachycardia. Patients will undergo standard of care mapping and ablation procedures.
Device: Rhythmia Mapping System
Arrhythmia mapping will be performed using the Rhythmia mapping system, including its mapping catheter, either in the atria or ventricles depending on the clinical arrhythmia being treated. Detailed mapping will be performed to determine tissue voltage and arrhythmia mechanism/location according to standard clinical practice. This part of the study will take approximately 90-120 minutes. The catheter position and contact will be visualized with intra-cardiac echocardiography, which is also routinely used during these procedures, and to monitor for potential clinically related complications. Images will be recorded to establish criteria for mapping.
Arrhythmia Mapping (Yes/No)
Ability to successfully map and characterize clinical arrhythmia as confirmed with conventional techniques.
Time frame: Enrollment (Clinical Procedure)
Ablation Success - Elimination of Clinical Arrhythmia (Yes/No)
Ability to ablate and eliminate the clinical arrhythmia
Time frame: Enrollment (Clinical Procedure)
Mapping Time (minutes)
Mapping time required to characterize the clinical arrhythmia
Time frame: Enrollment (Clinical Procedure)
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center