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NCT05111015Recruiting

Tracking Results of Ablations to Combat AF Registry Generation 2

AtriCure, Inc.

Start Date

3/11/2024

Completion Date

1/1/2040

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Open Concomitant Surgical Ablation Procedures

DEVICE

Hybrid (Convergent) Ablation Procedures

DEVICE

AtriCure Hybrid Totally Thoracoscopic Ablation Procedures

DEVICE

AtriCure LAA Exclusion Procedures

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Conditions

Atrial Fibrillation

Locations

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

Medical University of Vienna

Vienna,

Austria

Nova Scotia Health Authority

Halifax, Nova Scotia B3H3A7

Canada

Waterloo Regional Health Network

Kitchener, Ontario N2M1B2

Canada