Atrial FibrillationTRAC-AFNCT05111015
Tracking Results of Ablations to Combat AF Registry Generation 2
An observational study of Atrial Fibrillation, run by AtriCure, Inc. at 29 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Open Concomitant Surgical Ablation Procedures, Hybrid (Convergent) Ablation Procedures and AtriCure Hybrid Totally Thoracoscopic Ablation Procedures
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 29 sitesin 3 countries
- Study dates
- 11 Mar 2024to Jan 2040
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
29 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 3 countries
United States26 sites, 26 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
China Green, 734-936-7731, chjgreen@med.umich.edu
Matthew Romano, MD
- Recruiting
Maimonides Health Heart & Vascular Institute
Brooklyn, New York, 11219
Maria Nene, 718-283-7064, MNene2@maimo.org
Benjamin Youdelman, MD
- Recruiting
UH Cleveland Harrington Heart & Vascular Institute
Cleveland, Ohio, 44106
Shalena Finklea, 216-844-4033, Shalena.Finklea@uhhospitals.org
Gregory Rushing, MD
- Recruiting
Delray Medical Center
Delray Beach, Florida, 33484
Chris Minnerly
Jeffrey Newman, MD
- Recruiting
University of Florida
Gainesville, Florida, 32608
Jessica Cobb, 352-273-7837, jessica.cobb@surgery.ufl.edu
Thomas Beaver, MD
- Recruiting
Valley View Hospital
Glenwood Springs, Colorado, 81601
Kim Williams, 970-384-7433, kim.williams@vvh.org
Frank Laws, MD
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Tracy Wiles, 616-322-9447, tracy.wiles@corewellhealth.org
Charles Willekes, MD
- Recruiting
Michael E. DeBakey VAMC - Houston
Houston, Texas, 77030
Pawel Kolodziejski, 713-791-1414, pawelk@bcm.edu
Lorraine Cornwell, MD
- Recruiting
Huntsville Hospital
Huntsville, Alabama, 35801
Brittany Cope, 256-519-8268, bcope@theheartcenter.md
Franz Van Wagenberg, MD
- Recruiting
Franciscan Health
Indianapolis, Indiana, 46237
Erin Little
Marc Gerdisch, MD
- Recruiting
Jackson Madison County General Hospital
Jackson, Tennessee, 38301
Katherine Newman, 731-541-5000, katherine.newman@wth.org
Eric Sievers, MD
- Recruiting
St. Bernards Medical Center
Jonesboro, Arkansas, 72401
Connie Hill, 870-761-4426, chill@sbrmc.org
Jay Bhama, MD
- Recruiting
CHI St. Vincent Heart Institute
Little Rock, Arkansas, 72205
Lynn Bass, 501-552-8342, lynn.bass@commonspirit.org
Thomas Rayburn, MD
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92354
Kimberly Gilfillan, 909-558-4000, KGilfillan@llu.edu
Joshua Chung, MD
- Recruiting
Norton Heart & Vascular Institute
Louisville, Kentucky, 40222
Tara Mudd, 502-500-8917, Tara.Mudd@nortonhealthcare.org
Kent Morris, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
James Zelten, 414-955-8296, Jzelten@mcw.edu
Stefano Schena, MD
- Recruiting
Centennial Medical Center
Nashville, Tennessee, 37203
Abdullah Shamsuddin, 615-232-4735, abdullah.shamsuddin@hcahealthcare.com
Seenu Reddy, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mia Morrissey, 402-559-4601, mmorrissey1@unmc.edu
Brett Duncan, MD
- Recruiting
Orlando Health Heart & Vascular Institute
Orlando, Florida, 32806
George Ngo, 321-843-9657, george.ngo@orlandohealth.com
Karen Walker, MD
- Recruiting
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
Donita Atkins, 816-651-1969, Donita.Atkins@hcahealthcare.com
Dhanunjaya Lakkireddy, MD
- Recruiting
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Catherine Badia, 203-739-7643, catherine.badia@nuvancehealth.org
Gabriel Iacona, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Kyle Stumbaugh, 314-747-0707, kyles@wustl.edu
Ralph Damiano, MD
- Recruiting
Adventist Heart Institute (St. Helena Hospital)
St. Helena, California, 94574
Jennifer DeBattista, 707-963-3611, debattjl@ah.org
Gansevoort Dunnington, MD
- Recruiting
St. Joseph's Hospital (BayCare)
Tampa, Florida, 33607
Karen Herring, 813-875-9000, karen.herring@baycare.org
Andrew Sherman, MD
- Recruiting
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010
Katharine Mahoney, 202-877-2806, katharine.e.mahoney@medstar.net
Christian Shults, MD
- Recruiting
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Spencer Tingey, 336-713-0668, stingey@wakehealth.edu
Ted Kincaid, MD
Canada2 sites, 2 recruiting
- Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H3A7
Cynthia Ukeoma, 902-473-2847, cynthia.ukeoma@nshealth.ca
Philippe Tremblay, MD
- Recruiting
Waterloo Regional Health Network
Kitchener, Ontario, N2M1B2
Stephanie Nemirov, 519-749-4300, Stephanie.Nemirov@wrhn.ca
Jennifer Higgins, MD
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna
Katrin Bertha, +43 (0)1 40400-69895, katrin.bertha@meduniwien.ac.at
Emilio Osorio, MD
About this study
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.
Read the 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
- Being tested
- Open Concomitant Surgical Ablation Procedures, Hybrid (Convergent) Ablation Procedures, AtriCure Hybrid Totally Thoracoscopic Ablation Procedures, AtriCure LAA Exclusion Procedures
- Keywords
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Concomitant Surgical Ablation ProceduresDevice
AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
Hybrid (Convergent) Ablation ProceduresDevice
AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.
AtriCure Hybrid Totally Thoracoscopic Ablation ProceduresDevice
AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.
AtriCure LAA Exclusion ProceduresDevice
AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start11 Mar 2024
- Primary completionJan 2040 (estimated)
- Study completionJan 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- AtriCure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05111015
- Sponsor's protocol ID
- TRAC-AF Registry Generation 2
- Acronym
- TRAC-AF
- Status last verified
- Jun 2026
- First submitted
- 28 Oct 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Results of Ablations to Combat AF Registry Generation 2
- ClinicalTrials.gov ID
- NCT05111015
- Acronym / sponsor ID
- TRAC-AF / TRAC-AF Registry Generation 2
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- AtriCure, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- Jan 2040 (estimated)
- Study completion
- Jan 2040 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Concomitant Surgical Ablation ProceduresAtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation. | Device | – |
| Hybrid (Convergent) Ablation ProceduresAtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation. | Device | – |
| AtriCure Hybrid Totally Thoracoscopic Ablation ProceduresAtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation. | Device | – |
| AtriCure LAA Exclusion ProceduresAtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation. | Device | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by AtriCure, Inc. at 29 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Canada, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jarrod Goodarz, BA (609-331-6621, jgoodarz@atricure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's AF burden 6-month after receiving the ablation procedure (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.