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The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Manual guided RF ablation | Patients with paroxysmal atrial fibrillation treated with Manual guided RF ablation using Contact Force catheters | ||
| Cryoballoon ablation | Patients with paroxysmal atrial fibrillation treated with Cryoballoon ablation. Cryoballoon: Arctic Front Advance, Medtronic - 28 mm | ||
| RMN guided RF ablation - High power | Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings. High power ablation settings: a minimum of 40 Watt, 43grC, flow 17ml/min. Higher voltages (e.g. anterior wall) are allowed with respect to the operators' preference. | ||
| RMN guided RF ablation - Low power | Patients with paroxysmal atrial fibrillation treated with Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings. Low power ablation settings: a maximum of 39 Watt, 43grC, flow 17ml/min. Lower voltages are allowed with respect to the operators' preference. |
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| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | Procedure time (minutes) | During ablation procedure |
| Fluoroscopy time | Fluoroscopy time (minutes) | During ablation procedure |
| Transseptal time | Transseptal time (time from insertion of catheters until transseptal puncture) (minutes) | During ablation procedure |
| Left atrial dwell time | Left atrial dwell time (time from LA entry until removal of catheters) (minutes) | During ablation procedure |
| PVI ablation time | PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes) | During ablation procedure |
| Ablation time per pulmonary vein | Ablation time per pulmonary vein (minutes) | During ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| First Pass Isolation | First Pass Isolation (i.e. Successful isolation of PVs after the first ablation attempt) | During ablation procedure |
| Acute success | Acute success (Successful electrical isolation of PVs at the end of procedure) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for participation in the study have a reported incidence of at least two documented episodes of symptomatic paroxysmal atrial fibrillation during the three months preceding trial entry, as well as documentation of at least one episode of AF on ECG, and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Netwerk Antwerpen | Antwerp | Belgium | ||||
| Erasmus MC |
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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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| During ablation procedure |
| TouchUp rates | TouchUp rates (additional applications for successful PV isolation) | During ablation procedure |
| Long-term success | Long-term success (freedom of atrial fibrillation 12 months after ablation) | From the date of procedure until 1 year |
| Procedure-related adverse-events | Procedure-related adverse-events | From the date of procedure until 7 days |
| Long-term adverse events | Long-term adverse events | From the date of procedure until 1 year |
| Rotterdam |
| 3015CN |
| Netherlands |
| E. Meshalkin National medical research center | Novosibirsk | 630055 | Russia |
| D013568 |
| Pathological Conditions, Signs and Symptoms |