NCT05111015 · AtriCure, Inc.
Tracking Results of Ablations to Combat AF Registry Generation 2
(TRAC-AF)
What this study is 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Patient's AF burden 6-month after receiving the ablation procedure
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.
Adverse events of the ablation procedure as atrial fibrillation management
Time frame: 1 year
Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
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.
Where
- Huntsville, Alabama
- Jonesboro, Arkansas
- Little Rock, Arkansas
- Loma Linda, California
- St. Helena, California
- Glenwood Springs, Colorado
- Washington D.C., District of Columbia
- Delray Beach, Florida
- Gainesville, Florida
- Orlando, Florida
- Tampa, Florida
- Indianapolis, Indiana
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations