Tracking Results of Ablations to Combat AF Registry Generation 2

NCT ID: NCT05111015

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Study Completion Date

2030-01-31

Brief Summary

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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

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Open Concomitant Surgical Ablation Procedures

AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation.

Intervention Type DEVICE

Hybrid (Convergent) Ablation Procedures

AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation.

Intervention Type DEVICE

AtriCure Hybrid Totally Thoracoscopic Ablation Procedures

AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation.

Intervention Type DEVICE

AtriCure LAA Exclusion Procedures

AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AtriCure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Huntsville Hospital

Huntsville, Alabama, United States

Site Status RECRUITING

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status RECRUITING

CHI St. Vincent Heart Institute

Little Rock, Arkansas, United States

Site Status RECRUITING

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status RECRUITING

Adventist Heart Institute (St. Helena Hospital)

St. Helena, California, United States

Site Status RECRUITING

Valley View Hospital

Glenwood Springs, Colorado, United States

Site Status RECRUITING

MedStar Washington Hospital

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Delray Medical Center

Delray Beach, Florida, United States

Site Status RECRUITING

University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Orlando Health Heart & Vascular Institute

Orlando, Florida, United States

Site Status RECRUITING

St. Joseph's Hospital (BayCare)

Tampa, Florida, United States

Site Status RECRUITING

Franciscan Health

Indianapolis, Indiana, United States

Site Status RECRUITING

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Site Status RECRUITING

Norton Heart & Vascular Institute

Louisville, Kentucky, United States

Site Status RECRUITING

University of Michigan

Ann Arbor, Michigan, United States

Site Status RECRUITING

Corewell Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

Washington University School of Medicine

St Louis, Missouri, United States

Site Status RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Maimonides Health Heart & Vascular Institute

Brooklyn, New York, United States

Site Status RECRUITING

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Site Status RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status RECRUITING

UH Cleveland Harrington Heart & Vascular Institute

Cleveland, Ohio, United States

Site Status RECRUITING

Jackson Madison County General Hospital

Jackson, Tennessee, United States

Site Status RECRUITING

Centennial Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

Michael E. DeBakey VAMC - Houston

Houston, Texas, United States

Site Status RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Waterloo Regional Health Network

Kitchener, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Jarrod Goodarz, BA

Role: CONTACT

609-331-6621

Joey Stimler, DPT

Role: CONTACT

513-926-3875

Facility Contacts

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Brittany Cope

Role: primary

256-519-8268

Connie Hill

Role: primary

870-761-4426

Lynn Bass

Role: primary

501-552-8342

Kimberly Gilfillan

Role: primary

909-558-4000

Jennifer DeBattista

Role: primary

707-963-3611

Kim Williams

Role: primary

970-384-7433

Katharine Mahoney

Role: primary

202-877-2806

Chris Minnerly

Role: primary

Jessica Cobb

Role: primary

352-273-7837

George Ngo

Role: primary

321-843-9657

Karen Herring

Role: primary

813-875-9000

Erin Little

Role: primary

Donita Atkins

Role: primary

816-651-1969

Tara Mudd

Role: primary

502-500-8917

China Green

Role: primary

734-936-7731

Tracy Wiles

Role: primary

616-322-9447

Kyle Stumbaugh

Role: primary

314-747-0707

Mia Morrissey

Role: primary

402-559-4601

Maria Nene

Role: primary

718-283-7064

Catherine Badia

Role: primary

203-739-7643

Spencer Tingey

Role: primary

336-713-0668

Shalena Finklea

Role: primary

216-844-4033

Katherine Newman

Role: primary

731-541-5000

Abdullah Shamsuddin

Role: primary

615-232-4735

Pawel Kolodziejski

Role: primary

713-791-1414

James Zelten

Role: primary

414-955-8296

Cynthia Ukeoma

Role: primary

902-473-2847

Stephanie Nemirov

Role: primary

519-749-4300

Related Links

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Other Identifiers

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TRAC-AF Registry

Identifier Type: -

Identifier Source: org_study_id

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