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NCT Number: NCT05111015

Tracking Results of Ablations to Combat AF Registry Generation 2

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.

Treatment and study plan

Open Concomitant Surgical Ablation Procedures

Device

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

Hybrid (Convergent) Ablation Procedures

Device

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

AtriCure Hybrid Totally Thoracoscopic Ablation Procedures

Device

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

AtriCure LAA Exclusion Procedures

Device

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

Primary outcomes

  1. Patient's AF burden 6-month after receiving the ablation procedure

    Time frame: 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.

  2. Adverse events of the ablation procedure as atrial fibrillation management

    Time frame: 1 year

    Collect data on adverse events occurred during and post operation to assess the safety of the ablation procedure.

Other outcomes

  1. Medications

    Time frame: 12 months

    On/Off AAD or Anticoagulant post procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Jarrod Goodarz, BA

CONTACT

[email protected]

609-331-6621

Joey Stimler, DPT

CONTACT

[email protected]

513-926-3875

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Acronym: TRAC-AF

Important dates

Study start
2024
Primary completion
2040
Study completion
2040
First posted
Nov 8, 2021
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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