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

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05978466
• Lead Sponsor: CorVita Science Foundation

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

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants who had thrombo-embolic event	From enrollment to 10- year study completion	All strokes, transient ischemic and systemic thrombo-embolic events
Recurrence of Atrial fibrillation	From enrollment to 10- year study completion	The natural progression of the condition will be assessed per medical record review
Mortality	From enrollment to 10- year study completion	All cause death will be noted

Secondary Outcome Measures

Name	Time	Method
Number of participants who have experienced 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
Number of patients who have had pro-arrhythmia events	From enrollment to 10- year study completion	All pro-arrhythmic events will be documented and assessed
Number of patients who have had patient adherence events	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

Trial Locations

Locations (1)

CorVita Science Foundation (NFP); 🇺🇸 Chicago, Illinois, United States