MANAGE-AF Registry -MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)
Overview
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
Primary outcome measures
- Recurrence of Atrial fibrillation [Time frame: From enrollment to 10- year study completion]
- Number of participants who had thrombo-embolic event [Time frame: From enrollment to 10- year study completion]
- Mortality [Time frame: From enrollment to 10- year study completion]
Secondary outcome measures (4)
- Number of participants who have experienced bleeding [Time frame: From enrollment to 10- year study completion]
- Number of patients who have had pro-arrhythmia events [Time frame: From enrollment to 10- year study completion]
- Number of patients who have had patient adherence events [Time frame: From enrollment to 10- year study completion]
- Treatment complication [Time frame: From enrollment to 10- year study completion]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- CorVita Science Foundation (NFP) — Chicago
Identifiers
NCT: NCT05978466 · 2017-CSF-00100