Tracking Results of Ablations to Combat AF Registry Generation 2 (TRAC-AF)

June 26, 2026 updated by: AtriCure, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria
        • Recruiting
        • Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Emilio Osorio, MD
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H3A7
        • Recruiting
        • Nova Scotia Health Authority
        • Principal Investigator:
          • Philippe Tremblay, MD
        • Contact:
    • Ontario
      • Kitchener, Ontario, Canada, N2M1B2
        • Recruiting
        • Waterloo Regional Health Network
        • Contact:
        • Principal Investigator:
          • Jennifer Higgins, MD
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Huntsville Hospital
        • Contact:
        • Principal Investigator:
          • Franz Van Wagenberg, MD
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Recruiting
        • St. Bernards Medical Center
        • Principal Investigator:
          • Jay Bhama, MD
        • Contact:
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CHI St. Vincent Heart Institute
        • Contact:
        • Principal Investigator:
          • Thomas Rayburn, MD
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Principal Investigator:
          • Joshua Chung, MD
        • Contact:
      • St. Helena, California, United States, 94574
        • Recruiting
        • Adventist Heart Institute (St. Helena Hospital)
        • Contact:
        • Principal Investigator:
          • Gansevoort Dunnington, MD
    • Colorado
      • Glenwood Springs, Colorado, United States, 81601
        • Recruiting
        • Valley View Hospital
        • Principal Investigator:
          • Frank Laws, MD
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • MedStar Washington Hospital
        • Principal Investigator:
          • Christian Shults, MD
        • Contact:
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Recruiting
        • Delray Medical Center
        • Contact:
          • Chris Minnerly
        • Principal Investigator:
          • Jeffrey Newman, MD
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Thomas Beaver, MD
        • Contact:
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Orlando Health Heart & Vascular Institute
        • Contact:
        • Principal Investigator:
          • Karen Walker, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • St. Joseph's Hospital (BayCare)
        • Principal Investigator:
          • Andrew Sherman, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • Franciscan Health
        • Principal Investigator:
          • Marc Gerdisch, MD
        • Contact:
          • Erin Little
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute
        • Principal Investigator:
          • Dhanunjaya Lakkireddy, MD
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • Recruiting
        • Norton Heart & Vascular Institute
        • Principal Investigator:
          • Kent Morris, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Principal Investigator:
          • Matthew Romano, MD
        • Contact:
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
        • Principal Investigator:
          • Charles Willekes, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ralph Damiano, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Brett Duncan, MD
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11219
        • Recruiting
        • Maimonides Health Heart & Vascular Institute
        • Contact:
        • Principal Investigator:
          • Benjamin Youdelman, MD
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Vassar Brothers Medical Center
        • Contact:
        • Principal Investigator:
          • Gabriel Iacona, MD
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Atrium Health Wake Forest Baptist
        • Contact:
        • Principal Investigator:
          • Ted Kincaid, MD
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • UH Cleveland Harrington Heart & Vascular Institute
        • Principal Investigator:
          • Gregory Rushing, MD
        • Contact:
    • Tennessee
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Jackson Madison County General Hospital
        • Principal Investigator:
          • Eric Sievers, MD
        • Contact:
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • Michael E. DeBakey VAMC - Houston
        • Contact:
        • Principal Investigator:
          • Lorraine Cornwell, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Stefano Schena, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s)
  2. Patient is willing to provide informed consent
  3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Medications
Time Frame: 12 months
On/Off AAD or Anticoagulant post procedure
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AtriCure, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2040

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2040

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TRAC-AF Registry Generation 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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