Open Concomitant Surgical Ablation Procedures
DeviceAtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
NCT Number: NCT05111015
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Medical University of Vienna, Vienna, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.
AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.
AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.
Time frame: 6 months
Collect patient data on Atrial Fibrillation burden after the ablation procedure as documented by long term event monitoring or identified during the exam after a six-month recovery period.
Time frame: 1 year
Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure.
Time frame: 12 months
On/Off AAD or Anticoagulant post procedure
Contact information is provided by the study sponsor or research team.
Jarrod Goodarz, BA
CONTACT
Joey Stimler, DPT
CONTACT
AtriCure, Inc.
Industry
Acronym: TRAC-AF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05378035
Arrhythmias, Cardiac, Arterial Thromboembolism
Hong Kong
View Trial DetailsNCT07492524
Arrhythmias, Cardiac, Atrial Fibrillation
Yancheng, Dongtai, China
View Trial DetailsNCT07492498
Arrhythmias, Cardiac, Atrial Fibrillation
Yancheng, Dongtai, China
View Trial DetailsNCT06099730
Arrhythmias, Cardiac, Atrial Fibrillation
Jonesboro, Arkansas, United States
View Trial Details