ABLATOR Ablation Observational Registry

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

All patients who are indicated for an atrial fibrillation ablation procedure.

Exclusion Criteria

Pregnant women.

Primary Outcome Measures

Name	Time	Method
Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period.	12 months post procedure	Freedom from AF/AFL/AT (atrial fibrillation/atrial flutter/atrial tachycardia) with or without the use of anti-arrhythmic drugs after a 3-month blanking period. Repeat ablations during the 3-month blanking period do not count as effectiveness failures. A repeat ablation procedure after the 3-month blanking period is counted as an effectiveness failure.
Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs.	12 months post procedure	Procedure and/or Device-Related Cardiovascular SAE/SADEs. This registry collected information about adverse events deemed of cardiovascular origin ("Cardiovascular Serious Adverse Event") with the potential of leading to: * Death * A serious deterioration in the health of the subject * Fetal distress, fetal death or a congenital abnormality or birth defect A planned hospitalization for a pre-existing condition was not considered a serious adverse event. Reporting of non-serious events and non-cardiovascular events was not required.

Secondary Outcome Measures

Name	Time	Method

Locations (62): Allgemeines Krankenhaus Linz
🇦🇹
Linz, Austria
AZ Middelheim
🇧🇪
Antwerpen, Belgium
Jessa Ziekenhuis
🇧🇪
Hasselt, Belgium
CHR Citadelle
🇧🇪
Liège, Belgium
Foothills Medical Center
🇨🇦
Calgary, Canada
QE II Health Sciences
🇨🇦
Hailfax, Canada
Royal Jubilee hospital
🇨🇦
Newmarket, Canada
Institut de Cardiologie de Quebec (Hôpital Laval)
🇨🇦
Quebec, Canada
Fuwai Heart Hospital & Cardiovascular Institute
🇨🇳
Beijing, China
Third Xiangya Hospital of Central South University
🇨🇳
Changsha, China
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Allgemeines Krankenhaus Linz
🇦🇹Linz, Austria