ABLATOR Brazil - Ablation Observational Study (Registry)

Study Overview
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Brief Summary
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The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).

Detailed Description
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The objectives of this registry are the following: To confirm patient safety as part of the post market surveillance study. To assess performance of a combination of SJM products during procedures. To assess the learning curve with a combination of SJM products. To collect operator feedback on a combination of SJM products. All patients from participating sites who are indicated for an atrial fibrillation ablation procedure and willing to provide written Informed Consent may be enrolled in this registry. In order to ensure a minimum level of uniformity across site practices and to enable comparison of acute and long-term effectiveness as well as procedure efficiency according to technique used, a combination of 2 types of devices from the pre-specified list must be used to be eligible in this registry.

Official Title
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ABLATOR Brazil - Ablation Observational Study (Registry)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Observation / Data Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients who are indicated for an atrial fibrillation ablation procedure. Exclusion Criteria: Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation / Data Collection|The following data will be reviewed / collected: BASELINE VISIT: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history. ABLATION PROCEDURE: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence). 6 and 12 MONTH FOLLOW-UP (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unsuccessful treatment rate, measured by the number of repeated procedure | measured by the number of repeated procedure | within 12 months after ablation procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Serious Adverse Event | Reporting of SAE through the CRF | within 12 months after ablation procedure | 
| Death | Reporting of death through the CRF | within 12 months after ablation procedure |