Tracking Results of Ablations to Combat AF Registry (TRAC-AF)

February 3, 2023 updated by: AtriCure, Inc.

A Multicenter Patient Registry for Outcomes From Comprehensive Ablation Treatments of Atrial Arrhythmias

This is a global retrospective and prospective, multicenter, observational patient registry to record outcomes from patients undergoing ablations for the treatment of Atrial Fibrillation.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The TRAC-AF registry eligibility is open to sites and physicians performing Maze IV ablation procedures as treatments for patients diagnosed with paroxysmal, persistent or long-standing persistent atrial fibrillation using AtriCure Isolator® Synergy™ Clamp System and AtriCure AtriClip® LAA Exclusion System. Subjects must have been scheduled to undergo or have undergone the ablation treatment and must meet all eligibility criteria in order for their treatment and results to be considered for this registry.

Description

Inclusion Criteria:

  • Patient with a history of paroxysmal (intermittent), persistent or long-standing persistent atrial fibrillation and who have undergone or will undergo ablation treatment
  • Patient >= 18 years of age

Exclusion Criteria:

  • Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the global study manager
  • Subject with exclusion criteria required by FDA or local governance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AtriCure, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2027

Study Completion (ANTICIPATED)

January 1, 2027

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

October 28, 2021

First Posted (ACTUAL)

November 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAC_AF Outcomes 2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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