Registry for tracking results of heart ablation procedures
Tracking Results of Ablations to Combat AF Registry Generation 2
This study is tracking how well AtriCure devices work and their safety for patients who have had heart ablation procedures.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AtriCure, Inc. Industry-sponsored |
| Locations | 28 sites (Huntsville, Alabama and 27 other locations) |
| Trial ID | NCT05111015 on ClinicalTrials.gov |
What this trial studies
The TRAC-AF Registry aims to gather real-world data on the safety and effectiveness of AtriCure devices used in cardiac ablation procedures. It focuses on patients who are undergoing or have undergone open heart or hybrid ablation, including management of the Left Atrial Appendage. The collected data will inform product development, regulatory submissions, and scientific publications, ensuring that AtriCure remains updated on the performance of their devices in clinical settings.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for or who have undergone cardiac ablation procedures using AtriCure devices.
Not a fit: Patients enrolled in concurrent trials that may affect the treatment provided by the registry devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and effectiveness of atrial fibrillation treatments, leading to improved patient outcomes.
How similar studies have performed: Other studies have successfully utilized registries to track device performance and patient outcomes, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Huntsville, Alabama and 27 other locations
- Huntsville Hospital — Huntsville, Alabama, United States (Recruiting)
- St. Bernards Medical Center — Jonesboro, Arkansas, United States (Recruiting)
- CHI St. Vincent Heart Institute — Little Rock, Arkansas, United States (Recruiting)
- Loma Linda University Medical Center — Loma Linda, California, United States (Recruiting)
- Adventist Heart Institute (St. Helena Hospital) — St. Helena, California, United States (Recruiting)
- Valley View Hospital — Glenwood Springs, Colorado, United States (Recruiting)
- MedStar Washington Hospital — Washington D.C., District of Columbia, United States (Recruiting)
- Delray Medical Center — Delray Beach, Florida, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Orlando Health Heart & Vascular Institute — Orlando, Florida, United States (Recruiting)
- St. Joseph's Hospital (BayCare) — Tampa, Florida, United States (Recruiting)
- Franciscan Health — Indianapolis, Indiana, United States (Recruiting)
- Kansas City Heart Rhythm Institute — Overland Park, Kansas, United States (Recruiting)
- Norton Heart & Vascular Institute — Louisville, Kentucky, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Corewell Health — Grand Rapids, Michigan, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (Recruiting)
- Maimonides Health Heart & Vascular Institute — Brooklyn, New York, United States (Recruiting)
- Vassar Brothers Medical Center — Poughkeepsie, New York, United States (Recruiting)
- Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
- UH Cleveland Harrington Heart & Vascular Institute — Cleveland, Ohio, United States (Recruiting)
- Jackson Madison County General Hospital — Jackson, Tennessee, United States (Recruiting)
- Centennial Medical Center — Nashville, Tennessee, United States (Recruiting)
- Michael E. DeBakey VAMC - Houston — Houston, Texas, United States (Recruiting)
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
- Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
- Waterloo Regional Health Network — Kitchener, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Jarrod Goodarz, BA
- Email: jgoodarz@atricure.com
- Phone: 609-331-6621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.