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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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This study is to investigate the correlation and to obtain the coefficient of correlation between the global and local bipolar signals (voltage maps) of the LA in sinus rhythm using a focal 4.5 mm irrigated-tip ablation catheter (in combination with microelectrodes), a ring-electrode circular mapping catheter and a microelectrode multipolar catheter in combination with the Rhythmia system.
Current hypothesis of the mechanism of atrial fibrillation (AF) is a combination of local firing mainly triggered from the pulmonary veins and atrial substrate due to atrial remodelling sustaining AF. Whereas for paroxysmal AF, pulmonary vein isolation (PVI) is still the mainstay of interventional treatment, a left atrial (LA) substrate-based ablation especially in patients with persistent or long-standing persistent AF may be reasonable to improve freedom from AF. In addition, even in patients with paroxysmal AF, substrate-based ablation strategies have been shown to improve outcome. Substrate characterization of the LA is currently performed using the focal ablation catheter with a 3.5mm irrigated tip catheter with a 2 mm interelectrode spacing, a circular (Lasso) or spider like diagnostic (Pentaray) catheter with 1 mm size of the ring electrodes and 2 mm to 4 mm interelectrode spacing. Consequently, the cut-off values to delineate healthy tissue from diseased substrate are defined based on these measures. Since the electrode size and distance between the electrodes determines the bipolar voltage amplitude and morphology (beside their orientation with regard to the propagation wavefront), differences in bipolar voltage values must be expected between different catheter types and especially for the novel micro-electrode catheters IntellaMap Orion and IntellaNav MIFI OI. With the knowledge of the relationship between the bipolar voltage maps created with the different catheter types, information/knowledge from one study obtained with a specific catheter can be transferred to patients treated with the other catheter types. This study is to investigate the correlation and to obtain the coefficient of correlation between the global and local bipolar signals (voltage maps) of the LA in sinus rhythm using a focal 4.5 mm irrigated-tip ablation catheter (in combination with microelectrodes), a ring-electrode circular mapping catheter and a microelectrode multipolar catheter in combination with the Rhythmia system.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multipolar mapping catheter | Diagnostic Test | mapping of the left atrium will be performed in sinus rhythm using the IntellaMap Orion multipolar mapping catheter (Boston Scientific). | ||
| multielectrode circular catheter | Diagnostic Test | mapping of the left atrium will be performed using the multielectrode circular catheter (Lasso, spacing 2-6-2 mm, Biosense Webster) | ||
| irrigated ablation catheter | Diagnostic Test | mapping of the left atrium will be performed using the irrigated ablation catheter (IntellaNav Mifi OI) |
| Measure | Description | Time Frame |
|---|---|---|
| Global bipolar and unipolar signal measured in millivolt (mV) | Global bipolar and unipolar signal for the different types of catheters measured in mV | single time point assessment at baseline |
| Local bipolar and unipolar signal measured in mV | Local bipolar and unipolar signal for the different types of catheters measured in mV | single time point assessment at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Global fibrosis content and distribution from LGE-MRI measured in [%]. | Global fibrosis content and distribution from LGE-MRI measured in [%]. | single time point assessment at baseline |
| Local fibrosis content and distribution from Late-gadolinium enhanced Magnetic Resonance Imaging (LGE-MRI) measured in [%]. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing catheter ablation for atrial fibrillation at the University Hospital Basel
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| Name | Affiliation | Role |
|---|---|---|
| Michael Kuehne, Prof. Dr. | Cardiology/Electrophysiology, University Hospital Basel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology/Electrophysiology, University Hospital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39516302 | Derived | Schlageter V, Luca A, Badertscher P, Krisai P, Kueffer T, Spreen D, Katic J, Osswald S, Schaer B, Sticherling C, Kuhne M, Knecht S. Effect of electrode size and distance to tissue on unipolar and bipolar voltage electrograms and their implications for a near-field cutoff. Sci Rep. 2024 Nov 8;14(1):27184. doi: 10.1038/s41598-024-78627-5. |
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Local fibrosis content and distribution from LGE-MRI measured in [%]. |
| single time point assessment at baseline |
| Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV) | Differences of bipolar voltage characteristics between nearfield and farfield signals: amplitude (mV) | single time point assessment at baseline |
| Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency in Hertz (Hz) | Differences of bipolar voltage characteristics between nearfield and farfield signals: frequency (Hz) | single time point assessment at baseline |
| Differences of bipolar voltage characteristics between nearfield and farfield signals: Duration in milliseconds (ms) | Differences of bipolar voltage characteristics between nearfield and farfield signals: duration (ms) | single time point assessment at baseline |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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