NCT02344173

ABLATOR Ablation Observational Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,035 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-08-18
• Completion: 2017-08-18
• First posted: 2015-01-22
• Last updated: 2019-06-05
• Results posted: 2019-06-05

Locations

62 sites across 15 countries: Austria, Belgium, Canada, China, Czechia, France, Germany, India, Italy, Netherlands, Portugal, Saudi Arabia, South Korea, Spain, United Kingdom