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MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05978466
Acronym
MANAGE-AF
Enrollment
1000
Registered
2023-08-07
Start date
2017-12-22
Completion date
2027-12-31
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

atrial arrhythmia, atrial fibrillation, stroke, bleeding, Left Atrial Appendage Occlusion

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

Interventions

None listed

Sponsors

CorVita Science Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recurrence of Atrial fibrillationFrom enrollment to 10- year study completionThe natural progression of the condition will be assessed per medical record review
Number of participants who had thrombo-embolic eventFrom enrollment to 10- year study completionAll strokes, transient ischemic and systemic thrombo-embolic events
MortalityFrom enrollment to 10- year study completionAll cause death will be noted

Secondary

MeasureTime frameDescription
Number of participants who have experienced bleedingFrom enrollment to 10- year study completionAll bleeding events events will be will be assessed throughout the duration of the study per medical record review
Treatment complicationFrom enrollment to 10- year study completionAll adverse outcomes/events related to routine standard of care treatments will be noted and assessed for the duration of the study per medical record review
Number of patients who have had pro-arrhythmia eventsFrom enrollment to 10- year study completionAll pro-arrhythmic events will be documented and assessed
Number of patients who have had patient adherence eventsFrom enrollment to 10- year study completionEvents relating to subject non-compliance of medications will be documented for the duration of the study per medical record review

Countries

United States

Contacts

Primary ContactEdward M Burke
eddie@corvitahealth.org773-432-4888
Backup ContactMartin C Burke, DO
mburke@corvitahealth.org773-432-4888

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026