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

Sponsor

CorVita Science Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT05978466

Collaborator

(none)

1,000

Enrollment

Location

120.3

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation

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

Anticipated Enrollment :

1000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

Actual Study Start Date :

Dec 22, 2017

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Outcome Measures

Primary Outcome Measures

Recurrence of Atrial fibrillation [From enrollment to 10- year study completion]
The natural progression of the condition will be assessed per medical record review
Thrombo-embolic event [From enrollment to 10- year study completion]
All strokes, transient ischemic and systemic thrombo-embolic events
Mortality [From enrollment to 10- year study completion]
All cause death will be noted

Secondary Outcome Measures

Bleeding [From enrollment to 10- year study completion]
All bleeding events events will be will be assessed throughout the duration of the study per medical record review
Pro-arrhythmia [From enrollment to 10- year study completion]
All pro-arrhythmic events will be documented and assessed
Patient adherence [From enrollment to 10- year study completion]
Events relating to subject non-compliance of medications will be documented for the duration of the study per medical record review
Treatment complication [From enrollment to 10- year study completion]
All 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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