Tracking Results of Ablations to Combat AF Registry Generation 2
TRAC-AF
1 other identifier
observational
10,000
2 countries
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2013
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 28, 2021
CompletedFirst Posted
Study publicly available on registry
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
January 7, 2026
December 1, 2025
16.9 years
October 28, 2021
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
1 year
Other Outcomes (1)
Medications
12 months
Interventions
AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.
AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.
AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.
AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- \. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AtriCure, Inc.lead
Study Sites (28)
Huntsville Hospital
Huntsville, Alabama, 35801, United States
St. Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
CHI St. Vincent Heart Institute
Little Rock, Arkansas, 72205, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Adventist Heart Institute (St. Helena Hospital)
St. Helena, California, 94574, United States
Valley View Hospital
Glenwood Springs, Colorado, 81601, United States
MedStar Washington Hospital
Washington D.C., District of Columbia, 20010, United States
Delray Medical Center
Delray Beach, Florida, 33484, United States
University of Florida
Gainesville, Florida, 32608, United States
Orlando Health Heart & Vascular Institute
Orlando, Florida, 32806, United States
St. Joseph's Hospital (BayCare)
Tampa, Florida, 33607, United States
Franciscan Health
Indianapolis, Indiana, 46237, United States
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211, United States
Norton Heart & Vascular Institute
Louisville, Kentucky, 40222, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Maimonides Health Heart & Vascular Institute
Brooklyn, New York, 11219, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
UH Cleveland Harrington Heart & Vascular Institute
Cleveland, Ohio, 44106, United States
Jackson Madison County General Hospital
Jackson, Tennessee, 38301, United States
Centennial Medical Center
Nashville, Tennessee, 37203, United States
Michael E. DeBakey VAMC - Houston
Houston, Texas, 77030, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Nova Scotia Health Authority
Halifax, Nova Scotia, B3H3A7, Canada
Waterloo Regional Health Network
Kitchener, Ontario, N2M1B2, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2021
First Posted
November 8, 2021
Study Start
February 1, 2013
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
January 1, 2030
Last Updated
January 7, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share