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

AtriCure

Status: Enrolling

Conditions: Atrial Fibrillation

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05111015

TRAC-AF Registry

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 open concomitant and/or hybrid ablation, and management of the LAA concomitant to a cardiac ablation.

Full description

Up to 10,000 patients at up to 250 sites. Participating regions may include US, Canada, Europe, Asia Pacific and others to be determined. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias. Each patient will be followed for a period of up to ten (10) years after their procedure according to the standard practice at the enrolling center. There will be no additional visits, nor procedures, for subjects who participate in the registry.

Enrollment: 10,000 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)
2. Patient is willing to provide informed consent
3. Patient whose age is 18 years or above, or of legal age to give informed consent specific to state and national law

Exclusion criteria

1. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.