Tracking Results of Ablations to Combat AF Registry Generation 2

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05111015
• Lead Sponsor: AtriCure, Inc.

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 concomitant open heart and/or hybrid ablation, and management of the Left Atrial Appendage concomitant to a cardiac ablation.

Detailed Description

The TRAC-AF registry is a proactive measure for AtriCure to remain informed about the safety and effectiveness of their ablation devices and associated procedures under real-world use conditions. The analysis of the data from the registry may be used for product development efforts, regulatory submissions, and publications.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-08
• Status Verified: 2024-07
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2030-01
• Study Completion: 2030-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6400

Inclusion Criteria

1. Patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s) utilizing at least one AtriCure device.

   EXCEPTION: Participating registry sites that wish to compare AtriCure devices, and their associated procedures' safety and effectiveness, with other therapies for the management of cardiac diseases, can include patients who did not receive treatment with an AtriCure device, but were treated or will be treated for similar baseline disease state.

2. Patient is willing to provide written informed consent, (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry), or authorization per institution and geographical requirements.

Exclusion Criteria

1. Patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices.
2. Patient with exclusion criteria required by local governance.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient's AF burden 6-month after receiving the ablation procedure	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.
Adverse events of the ablation procedure as atrial fibrillation management	1 year	Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure.

Trial Locations

Locations (11)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Adventist Heart Institute (St. Helena Hospital); 🇺🇸 Saint Helena, California, United States

MedStar Washington Hospital; 🇺🇸 Washington, District of Columbia, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

St. Joseph's Hospital (BayCare); 🇺🇸 Tampa, Florida, United States

Kansas City Cardiac Arrhythmia Research; 🇺🇸 Kansas City, Missouri, United States

Jackson Madison County General Hospital; 🇺🇸 Jackson, Tennessee, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Royal University Hospital; 🇨🇦 Saskatoon, Saskatchewan, Canada

Delray Medical Center; 🇺🇸 Delray Beach, Florida, United States

Franciscan Health; 🇺🇸 Indianapolis, Indiana, United States