MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Number of participants who had thrombo-embolic event
Study Overview
Brief Summary
The purpose of this research is to learn more about the normal care of patients with a new or pre-existing diagnosis of atrial fibrillation (AF). These abnormal and irregular heartbeats place patients at increased risk of developing clots in their bloodstream that could potentially lead to stroke. Normal care is designed to help prevent this from happening and to lessen or eliminate the symptoms patients may have. There are many different types of AF as well as numerous ways in which a variety of patients are treated. The investigators are interested in gathering more information to better keep track of patient treatment patterns (trends) that may differ from physician to physician, hospital to hospital, medication to medication, patient to patient and if necessary, procedure to procedure.
Detailed Description
The objective of this research is to establish a contemporary and simple to construct AF management registry that expands progressively over the continuum of care for each individual patient. The registry will be used to determine the course and progression of AF management in preventing thrombo-embolic events using rhythm and rate control interventions.
Primary endpoints:
- Atrial fibrillation natural history
- Thrombo-embolic event
- Death
Secondary endpoints:
- Bleeding
- Pro-arrhythmia
- Patient adherence
- Treatment complication
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of valvular or non valvular atrial fibrillation
- •ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder
Exclusion Criteria
- •Age below 18 years.
- •Clinical evidence that death within 6 months is possible
- •Inability to consent to the research or sign a consent form
- •Inability to follow up at the research clinic at least annually for continuity of AF care and management
Outcomes
Primary Outcomes
Number of participants who had thrombo-embolic event
Time Frame: From enrollment to 10- year study completion
All strokes, transient ischemic and systemic thrombo-embolic events
Recurrence of Atrial fibrillation
Time Frame: From enrollment to 10- year study completion
The natural progression of the condition will be assessed per medical record review
Mortality
Time Frame: From enrollment to 10- year study completion
All cause death will be noted
Secondary Outcomes
- Number of participants who have experienced bleeding(From enrollment to 10- year study completion)
- Number of patients who have had pro-arrhythmia events(From enrollment to 10- year study completion)
- Number of patients who have had patient adherence events(From enrollment to 10- year study completion)
- Treatment complication(From enrollment to 10- year study completion)