Tracking Results of Ablations to Combat AF Registry Generation 2 (TRAC-AF)

AtriCure

Status: Enrolling

Conditions: Atrial Fibrillation

Treatments: Device: Hybrid (Convergent) Ablation Procedures; Device: Concomitant Open Heart Surgical Ablation Procedures; Device: AtriCure Hybrid Totally Thoracoscopic Ablation Procedures; Device: AtriCure LAA Exclusion Procedures

Study type: Observational

Funder types: Industry

Identifiers

NCT05111015

TRAC_AF Outcomes 2017

Details and patient eligibility

About

The primary objective of the TRAC-AF Registry is to capture real-world safety and effectiveness data on AtriCure devices used to conduct concomitant open heart and/or hybrid ablation, and management of the Left Atrial Appendage concomitant to a cardiac ablation.

Full description

The TRAC-AF registry is a proactive measure for AtriCure to remain informed about the safety and effectiveness of their ablation devices and associated procedures under real-world use conditions. The analysis of the data from the registry may be used for product development efforts, regulatory submissions, and publications.

Enrollment: 6,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.