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

January 6, 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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 Backup

Study Locations

  • 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

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

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

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

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)

February 1, 2013

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAC-AF Registry

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.

Clinical Trials on Atrial Fibrillation

Clinical Trials on Open Concomitant Surgical Ablation Procedures

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe