Tracking Results of Ablations to Combat AF Registry Generation 2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Open Concomitant Surgical Ablation Procedures, Hybrid (Convergent) Ablation Procedures, AtriCure Hybrid Totally Thoracoscopic Ablation Procedures, AtriCure LAA Exclusion Procedures.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Open Concomitant Surgical Ablation Procedures
AtriCure's Open Concomitant Surgical Ablation Devices used for the management of Atrial Fibrillation. - Device Hybrid (Convergent) Ablation Procedures
AtriCure's Hybrid (Convergent) Ablation Devices used for the management of Atrial Fibrillation. - Device AtriCure Hybrid Totally Thoracoscopic Ablation Procedures
AtriCure's Hybrid Totally Thoracoscopic Surgical Ablation Devices used for the management of Atrial Fibrillation. - Device AtriCure LAA Exclusion Procedures
AtriCure's LAA Exclusion Devices used to exclude the Left Atrial Appendage for the management of Atrial Fibrillation.
Primary outcome measures
- 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]
Eligibility criteria
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
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 26 centers
- Huntsville Hospital — Huntsville
- St. Bernards Medical Center — Jonesboro
- CHI St. Vincent Heart Institute — Little Rock
- Loma Linda University Medical Center — Loma Linda
- Adventist Heart Institute (St. Helena Hospital) — St. Helena
- Valley View Hospital — Glenwood Springs
- MedStar Washington Hospital — Washington D.C.
- Delray Medical Center — Delray Beach
- … and 18 more centers
Canada · 2 centers
- Nova Scotia Health Authority — Halifax
- Waterloo Regional Health Network — Kitchener
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT05111015 · TRAC-AF Registry Generation 2