Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Sponsor St. Jude Medical
Start date November 2014
End date November 2017
Trial size 2007 participants
Trial identifier NCT02344173, CRD_723

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation.
time frame: after follow-up of 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title ABLATOR Ablation Observational Registry
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.