None listed
Conditions
Brief summary
Activation, Entrainment and Pace mapping techniques has been the mainstay of the catheter based mapping and ablation of all atrial arrhythmias. The original studies describing these mapping techniques were performed almost two decades ago. These studies were performed using fluoroscopy alone without the aid of a 3D electroanatomical mapping system. Indeed all published mapping and entrainment studies have been performed using catheters with a large (4mm or 8mm) distal tip of the roving mapping catheter. These studies are yet to be repeated using the newly available catheter technology. Indeed there is no data on the accuracy of activation, entrainment and pace mapping using these ‘new generation’ of mapping catheters with small micro electrodes and narrow bipolar spacing. Hence the aim of this study is to perform detailed activation, entrainment and pace mapping in a variety of atrial arrhythmias in order to validate the classical mapping criteria and techniques using these new catheters.
Interventions
To evaluate the resolution and accuracy of the Rhythmia mapping system and new high spatial resolution catheters in the mapping of atrial arrhythmias. The two novel high spatial resolution catheters called the IntellaTip-MiFi and IntellaMap-Orion have micro electrodes at the catheter tip with very narrow spacing between adjacent recording electrodes resulting in a 2-5 x increase in spatial resolution compared to standard mapping catheters. The IntellaTip MiFi catheters have 3 'micro' electrodes
To evaluate the resolution and accuracy of the Rhythmia mapping system and new high spatial resolution catheters in the mapping of atrial arrhythmias. The two novel high spatial resolution catheters called the IntellaTip-MiFi and IntellaMap-Orion have micro electrodes at the catheter tip with very narrow spacing between adjacent recording electrodes resulting in a 2-5 x increase in spatial resolution compared to standard mapping catheters. The IntellaTip MiFi catheters have 3 'micro' electrodes at the tip of the catheter with an inter-electrode distance of 0.8mm. The IntellaMap-Orion catheter has 64 individual micro electrodes with a 2.5mm inter-electrode spacing. Both catheters have a much smaller electrode size and narrower inter-electrode distance compared to the 3.4 to 5mm tipped mapping catheters that are currently available. The Rhythmia mapping system allows real-time automated signal analysis, which means electrical maps can be created in real-time as opposed to the time consuming off-line analysis that is required currently. The system uses an automated annotation algorithm that determines local activation time and builds a 3D activation map as each point is acquired. In theory the combination of the 2.5mm inter-electrode space IntellaMap-Orion basket catheter coupled with the automated electrogram annotation would allow a highly detailed activation map to be created in minimal time. Depending on the complexity of the patient's arrhythmia, the case make take approximately an hour. The detailed mapping will be performed by an experienced cardiologist. The outcome timepoint would be accurate identification of the arrhythmia circuit and site of focal activation.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients having mapping and ablation of atrial arrhythmias (focal atrial tachycardia and macro-reentrant atrial flutter).
Exclusion criteria
1. Uncontrolled hypertension. 2. Known coagulopathy or thrombophilia 3. Inability to provide informed consent (e.g. people with an intellectual or mental impairment) 4. Women who are pregnant 5. Children and/or young people (ie. <18 years)
Outcome results
None listed