NCT05111015

Tracking Results of Ablations to Combat AF Registry Generation 2

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 10,000 (estimated)
• Sponsor: AtriCure, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Open Concomitant Surgical Ablation Procedures	AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
DEVICE	Hybrid (Convergent) Ablation Procedures	AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.
DEVICE	AtriCure Hybrid Totally Thoracoscopic Ablation Procedures	AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.
DEVICE	AtriCure LAA Exclusion Procedures	AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.

Timeline

• Start date: 2013-02-01
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2021-11-08
• Last updated: 2026-01-07

Locations

28 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study