Participation

• Hospitals must participate in the American Heart Association’s Get With The Guidelines^® – AFib (GWTG-AFib) Registry
• Hospitals must be research-ready (e.g., have processes and systems for obtaining IRB approval)
• If your hospital is not part of GWTG-AFib and would like to learn more about joining, email [email protected]

The trial is targeting 200 U.S. based hospitals to enroll 3,000 patients.

Data are collected in the American Heart Association’s Get With The Guidelines® – AFib (GWTG-AFib) Registry.

Yes, a Program Director and Trial Program Manager will actively support all participating hospitals and will be available to address any trial-related questions. Once a site is signed up for the trial, the site can expect in depth training on trial protocols, patient selection, and data entry as well as ongoing support throughout the trial.

There will be a minimal amount of additional data collection for the hospitalization episode. You will also collect data at two follow-up points:

1. A mid-way time point, approximately 6 months post discharge
2. An end-of-study time point at 12 months post discharge

Sites will complete a Unified Participation Agreement (UPA), the official contract between the American Heart Association and the Participating Site, that allows the site to enroll and have access to AHA’s Get With The Guidelines on the registry platform. Sites already participating in GWTG-AFib with a UPA in place do not need to sign the UPA. Sites enrolled in a GWTG module other than AFib will sign an amendment to their existing UPA.

All sites will need to also sign the individual Participating Site Agreement which complements the UPA and outlines what the Participating Site is responsible for during the CHANGE AFib trial. The Site Agreement details what the CHANGE AFib trial will cover and formally outlines each parties understanding and responsibilities for conducting the trial. A Participating Site is required to sign both the UPA and the Site Agreement in order to participate in the CHANGE AFib trial.

Yes.

No.

Some sites participating in CHANGE-AFib may already have their own IRBs to oversee research conducted within the institution or by staff of the institution. Your site may use your own IRB to participate.

For those sites without an IRB, FDA regulations permit an institution without an IRB to arrange for an “outside” IRB to be responsible for initial and continuing review of studies conducted at a non-IRB institution. A central IRB has been established for CHANGE-AFib; AHA and DCRI staff can help a site navigate the process.

Inclusion Criteria
Participants are eligible to be included in the trial if ALL the following apply:

• Age 21 years or older
• First-detected AFib (defined as AFib diagnosed in the previous 120 days)
• Acute care encounter for evaluation or treatment of atrial fibrillation, within 120 days
• Electrocardiographic documentation of atrial fibrillation
• Estimated life expectancy of at least 1 year
• Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) of the trial protocol

Exclusion Criteria
Participants are excluded from the trial if ANY of the following criteria apply:

• Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy
• Prior hospitalization for AFib (other than the qualifying event)
• Planned cardiothoracic surgery
• New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks
• Reduced ejection fraction (LVEF ≤40%)
• Permanent atrial fibrillation
• Ineligible for oral anticoagulation, unless CHA₂DS₂-VASc is less than 3, in women, or 2, in men.
• Bradycardia with a resting heart rate < 50 bpm
• PR interval >280 msec or 2^nd degree or 3^rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device
• Corrected QT interval ³500 msec
• Pregnancy or breast feeding
• Severe hepatic impairment in the opinion of the investigator

There are no randomized clinical trials that address first-detected AFib treatment. Patients are often started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker). The trial is investigating if earlier administration of a well-tolerated antiarrhythmic drug, shown to reduce hospitalization, may result in improved cardiovascular outcomes and quality of life in patients.

Patients may be enrolled through December 2024.

YES. Get With The Guidelines – Atrial Fibrillation is an in-patient registry, however, outpatient enrollment is not prohibited. If you encounter a person who meets the inclusion and exclusion criteria and has recently been diagnosed with atrial fibrillation in the past 120 days, then they can be enrolled and randomized from clinic or the outpatient setting. If this occurs, there are several important things to keep in mind.

• As stated in the protocol, subjects must have a new diagnosis of atrial fibrillation within 120 days of randomization.
• If a participant a subject is randomized to the intervention (dronedarone) arm, they must be registered in the Almac Simplify^TM IRT System to facilitate study drug shipment and dispensation.
• Study teams are responsible for registration of intervention arm subjects in the IRT System, completing the study drug order request process, and conducting confirmation conversations of study drug delivery and dosing initiation.
• Their baseline case report form needs to be filled out completely with information from their qualifying acute care encounter.
• The redcap database will need to be completed to allow randomization and treatment assignment.

In order to be eligible for CHANGE AFIB, a patient must have had an acute care encounter at the hospital for atrial fibrillation. For eligibility, this is defined as an acute care encounter and discharge from the emergency room, observation unit, or an inpatient admission.

A cardioversion is allowed at any time during the conduct of the trial (in either arm).

There are two pre-specified follow-up encounters.

• The first occurs approximately 6 months after randomization (with an visit window between 3 and 9 months). This encounter can be either in-person or through virtual assessment. At the 6-month visit, the 6-month follow-up form is completed in the GWTG-AFib registry.
• The second is the final follow-up encounter and occurs 12-months post randomization. Similar to the 6-month encounter, the final visit can be conducted either in-person or through virtual assessment. At the 12-month encounter, the 12-month follow-up form is completed in the GWTG-AFib registry. Patients who withdraw early or experience mortality will also have the final follow-up form completed.