Recruiting

Ablations

Sponsor:

AtriCure, Inc.

Code:

NCT05111015

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Open Concomitant Surgical Ablation Procedures

Hybrid (Convergent) Ablation Procedures

AtriCure Hybrid Totally Thoracoscopic Ablation Procedures

AtriCure LAA Exclusion Procedures

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT05111015

Start date

Mar 11, 2024

Status verified date

Jun, 2026

Completion date

Jan, 2040

Anticipated

Primary completion date

Jan, 2040

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Open Concomitant Surgical Ablation Procedures

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

Hybrid (Convergent) Ablation Procedures

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

AtriCure Hybrid Totally Thoracoscopic Ablation Procedures

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

AtriCure LAA Exclusion Procedures

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

Primary outcome measure

  • Patient's AF burden 6-month after receiving the ablation procedure [ Time Frame: 6 months ]
  • Adverse events of the ablation procedure as atrial fibrillation management [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Huntsville Hospital

Recruiting

Huntsville, Alabama, United States, 35801

Contacts

Principal Investigator:

Franz Van Wagenberg, MD

St. Bernards Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Principal Investigator:

Jay Bhama, MD

CHI St. Vincent Heart Institute

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Principal Investigator:

Thomas Rayburn, MD

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92354

Contacts

Principal Investigator:

Joshua Chung, MD

Adventist Heart Institute (St. Helena Hospital)

Recruiting

St. Helena, California, United States, 94574

Contacts

Jennifer DeBattista

707-963-3611debattjl@ah.org

Principal Investigator:

Gansevoort Dunnington, MD

Valley View Hospital

Recruiting

Glenwood Springs, Colorado, United States, 81601

Contacts

Principal Investigator:

Frank Laws, MD

MedStar Washington Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20010

Contacts

Principal Investigator:

Christian Shults, MD

Delray Medical Center

Recruiting

Delray Beach, Florida, United States, 33484

Principal Investigator:

Jeffrey Newman, MD

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Principal Investigator:

Thomas Beaver, MD

Orlando Health Heart & Vascular Institute

Recruiting

Orlando, Florida, United States, 32806

Contacts

Principal Investigator:

Karen Walker, MD

St. Joseph's Hospital (BayCare)

Recruiting

Tampa, Florida, United States, 33607

Contacts

Principal Investigator:

Andrew Sherman, MD

Franciscan Health

Recruiting

Indianapolis, Indiana, United States, 46237

Principal Investigator:

Marc Gerdisch, MD

Kansas City Heart Rhythm Institute

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Principal Investigator:

Dhanunjaya Lakkireddy, MD

Norton Heart & Vascular Institute

Recruiting

Louisville, Kentucky, United States, 40222

Contacts

Principal Investigator:

Kent Morris, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Matthew Romano, MD

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Principal Investigator:

Charles Willekes, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Principal Investigator:

Ralph Damiano, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Principal Investigator:

Brett Duncan, MD

Maimonides Health Heart & Vascular Institute

Recruiting

Brooklyn, New York, United States, 11219

Contacts

Principal Investigator:

Benjamin Youdelman, MD

Vassar Brothers Medical Center

Recruiting

Poughkeepsie, New York, United States, 12601

Contacts

Principal Investigator:

Gabriel Iacona, MD

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Principal Investigator:

Ted Kincaid, MD

UH Cleveland Harrington Heart & Vascular Institute

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Gregory Rushing, MD

Jackson Madison County General Hospital

Recruiting

Jackson, Tennessee, United States, 38301

Contacts

Principal Investigator:

Eric Sievers, MD

Centennial Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Principal Investigator:

Seenu Reddy, MD

Michael E. DeBakey VAMC - Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Pawel Kolodziejski

713-791-1414pawelk@bcm.edu

Principal Investigator:

Lorraine Cornwell, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Principal Investigator:

Stefano Schena, MD

Nova Scotia Health Authority

Recruiting

Halifax, Nova Scotia, Canada, B3H3A7

Contacts

Principal Investigator:

Philippe Tremblay, MD

Waterloo Regional Health Network

Recruiting

Kitchener, Ontario, Canada, N2M1B2

Contacts

Principal Investigator:

Jennifer Higgins, MD

More Information

Sponsor

AtriCure, Inc.

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • Atrial Fibrillation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AtriCure, Inc. on 2026-06-29.