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The LOWE AF HD is a prospective, single-center, non-randomized study to assess safety, efficacy, acute and long-term outcome data of a specific ablation approach as treatment of paroxysmal atrial fibrillation.
Pulmonary vein isolation using radiofrequency (RF) ablation is acknowledged used treatment strategy for atrial fibrillation, many different approaches are recently implemented. The specific approach used in this study includes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Power Atrial Fibrillation Ablation | In our center, routine medical care for atrial fibrillation ablation includes:
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| Measure | Description | Time Frame |
|---|---|---|
| Acute Procedural Success Rate | Acute procedural success defined as electrical isolation of all pulmonary veins, confirmed by the high-density voltage remap and loss of pace capture along ablation line after complete isolation. | 1 day |
| Rate of patients without Atrial Fibrillation recurrences | Freedom from Atrial Fibrillation (AF) defined as any documented recurrence of AF and/or atrial tachycardia (AT) and /or atrial flutter (AFL), lasting longer than 30 second, assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR). | 12 months after 3-months blanking period |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events rate | Procedural and post procedural safety assessed by reporting all adverse events in the first 30 days after ablation | 1 month |
| Ablation Procedure Time | Complete procedure time (minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients eligible for participation in the study have indication for ablation of paroxysmal AF and are eligible for PVI by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregorio Covino, MD | Contact | +39 0812545350 | elettroSGB@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gregorio Covino, MD | Ospedale San Giovanni Bosco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Giovanni Bosco | Naples | 80100 | Italy |
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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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| 1 day |
| Ablation Fluoroscopic Time | Fluoroscopic time recorded (minutes) during ablation procedure | 1 day |
| Number of radiofrequency applications | Number of radiofrequency applications reported for each patient during ablation procedure. | 1 day |
| Total radiofrequency ablation time | Total time (minutes) of radiofrequency applications in each patient during ablation procedure. | 1 day |
| First pass pulmonary vein isolation | Number of patients in which PV isolation is obtained at first attempt. | 1 day |
| Number of atrial fibrillation events | Number of AF events symptomatic and asymptomatic assessed from the end of the 3-months blanking period to 12 months following a single ablation procedure and collected by Implantable Loop Recorder (ILR). | 12 months |
| Atrial Fibrillation Burden | AF Burden (in minutes) recorded at 12 months (after 3-months blanking period) of follow-up by Implantable Loop Recorder. | 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |