Clinical trial NCT05111015: Tracking Results of Ablations to Combat AF Registry Generation 2
Official title: A Multicenter Patient Registry for Outcomes From Comprehensive Ablation Treatments of Atrial Arrhythmias
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 6400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The TRAC-AF registry eligibility is open to sites and physicians performing concomitant open heart or hybrid ablation therapy procedures as treatments for patients diagnosed with paroxysmal, persistent or long-standing persistent atrial fibrillation using at least one of AtriCure's ablation devices. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient's AF burden 6-month after receiving the ablation procedure
timeFrame: 6 months
measure: Adverse events of the ablation procedure as atrial fibrillation management
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Saint Helena
country: United States
facility: Adventist Heart Institute (St. Helena Hospital)
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital
state: District of Columbia
city: Delray Beach
country: United States
facility: Delray Medical Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: St. Joseph's Hospital (BayCare)
state: Florida
city: Indianapolis
country: United States
facility: Franciscan Health
state: Indiana
city: Kansas City
country: United States
facility: Kansas City Cardiac Arrhythmia Research
state: Missouri
city: Jackson
country: United States
facility: Jackson Madison County General Hospital
state: Tennessee
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
References: