Tracking Results of Ablations to Combat AF Registry Generation 2

Launched by ATRICURE, INC. · Oct 28, 2021

Keywords

ClinConnect Summary

The TRAC-AF Registry is a study designed to gather important information about the safety and effectiveness of AtriCure devices used during heart surgeries, particularly for a condition called atrial fibrillation (AF). This trial aims to understand how well these devices work in real-life situations, especially when they are used to perform a procedure known as ablation, which helps control the heart's rhythm. If you are someone who has been scheduled for this type of surgery or have already had it using an AtriCure device, you may be eligible to participate in this study.

To join, you need to be willing to sign a consent form agreeing to take part in the registry, and it is important that you are having surgery with an AtriCure device. However, if you are in another study that might affect your treatment, or if there are specific local rules that apply to you, you may not be able to participate. If you decide to take part, you will help researchers collect valuable data that could improve future treatments for people with similar heart conditions. This study is currently recruiting participants of all ages and genders, and your involvement could contribute to better understanding and management of atrial fibrillation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s) utilizing at least one AtriCure device.
• • EXCEPTION: Participating registry sites that wish to compare AtriCure devices, and their associated procedures' safety and effectiveness, with other therapies for the management of cardiac diseases, can include patients who did not receive treatment with an AtriCure device, but were treated or will be treated for similar baseline disease state.
• • 2. Patient is willing to provide written informed consent, (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry), or authorization per institution and geographical requirements.
• Exclusion Criteria:
• • 1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
• • 2. Patient with exclusion criteria required by local governance.