Tracking Results of Ablations to Combat AF Registry Generation 2
ConditionAtrial Fibrillation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAtriCure, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s)
Patient is willing to provide informed consent
Patient whose age is 18 years or above, or of legal age to give informed consent specific to state and national law
Disqualifiers
None
Trial population
The TRAC-AF registry eligibility is open to sites and physicians performing open concomitant or hybrid ablation therapy procedures as treatments for patients diagnosed with paroxysmal, persistent or long-standing persistent atrial fibrillation using at least one of AtriCure's ablation devices. Subjects must have been scheduled to undergo or have undergone the cardiac ablation treatment and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Open Concomitant Surgical Ablation Procedures
DeviceAtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
Hybrid (Convergent) Ablation Procedures
DeviceAtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.
AtriCure Hybrid Totally Thoracoscopic Ablation Procedures
DeviceAtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.
AtriCure LAA Exclusion Procedures
DeviceAtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Patient's AF burden 6-month after receiving the ablation procedure
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
6 months2
Adverse events of the ablation procedure as atrial fibrillation management
Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure.
Time frame
1 yearOther outcomes
1
Medications
On/Off AAD or Anticoagulant post procedure
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov