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This is a pilot study to collect unipolar signal data during a pulsed field ablation study for the treatment of atrial fibrillation and to test the performance of an algorithm designed to measure the local potential of the unipolar signal in real time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| De Novo PFA ablation |
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| Measure | Description | Time Frame |
|---|---|---|
| PFAnalyzer output | The automated peak-to-peak voltage of the local signal potential output from the PFAnalyzer will be compared to manual measurement of both unipolar and bipolar signals. | From enrollment to hospital discharge typically 1 day |
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Inclusion Criteria:
Male or non-pregnant female aged ≥18 years.
Able and willing to provide written informed consent prior to any clinical investigation related procedure
Exclusion Criteria:
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Paroxysmal and persistent atrial fibrillation patients referred for a cardiac ablation using pulsed field ablation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KBC Split | Split | 21000 | Croatia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |