Clinical trial NCT05978466: MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
Official title: MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial arrhythmia
atrial fibrillation
stroke
bleeding
Left Atrial Appendage Occlusion
Lead sponsor: CorVita Science Foundation
Sponsor class: OTHER
First posted: 2023-08-07
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects with the diagnosis of atrial fibrillation can be enrolled into the study regardless of sex, age or medical history

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:

1. Atrial fibrillation natural history
2. Thrombo-embolic event
3. Death

Secondary endpoints:

1. Bleeding
2. Pro-arrhythmia
3. Patient adherence
4. Treatment complication

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of valvular or non valvular atrial fibrillation
2. ECG documented atrial fibrillation A. 12 lead B. Rhythm strip C. Event monitor D. Holter Monitor E. Implantable loop recorder

Exclusion Criteria:

1. Age below 18 years.
2. Clinical evidence that death within 6 months is possible
3. Inability to consent to the research or sign a consent form
4. Inability to follow up at the research clinic at least annually for continuity of AF care and management

Primary outcomes:
measure: Recurrence of Atrial fibrillation
timeFrame: From enrollment to 10- year study completion
measure: Number of participants who had thrombo-embolic event
timeFrame: From enrollment to 10- year study completion
measure: Mortality
timeFrame: From enrollment to 10- year study completion
Secondary outcomes:
measure: Number of participants who have experienced bleeding
timeFrame: From enrollment to 10- year study completion
measure: Number of patients who have had pro-arrhythmia events
timeFrame: From enrollment to 10- year study completion
measure: Number of patients who have had patient adherence events
timeFrame: From enrollment to 10- year study completion
measure: Treatment complication
timeFrame: From enrollment to 10- year study completion
Other outcomes:
Locations:
city: Chicago
country: United States
facility: CorVita Science Foundation (NFP)
state: Illinois
Study officials:
affiliation: Chief Scientific Officer
name: Martin C Burke, DO
role: PRINCIPAL_INVESTIGATOR
References: