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

Atrial Fibrillation Clinical Trial

— MANAGE-AF  

Official title:

MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978466
• Other study ID #: 2017-CSF-00100
• Status: Recruiting
• Start date: December 22, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: CorVita Science Foundation
• Contact: Edward M Burke
• Phone: 773-432-4888
• Email: eddie[@]corvitahealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United States	CorVita Science Foundation (NFP)	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
CorVita Science Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of Atrial fibrillation	The natural progression of the condition will be assessed per medical record review	From enrollment to 10- year study completion
Primary	Number of participants who had thrombo-embolic event	All strokes, transient ischemic and systemic thrombo-embolic events	From enrollment to 10- year study completion
Primary	Mortality	All cause death will be noted	From enrollment to 10- year study completion
Secondary	Number of participants who have experienced bleeding	All bleeding events events will be will be assessed throughout the duration of the study per medical record review	From enrollment to 10- year study completion
Secondary	Number of patients who have had pro-arrhythmia events	All pro-arrhythmic events will be documented and assessed	From enrollment to 10- year study completion
Secondary	Number of patients who have had patient adherence events	Events relating to subject non-compliance of medications will be documented for the duration of the study per medical record review	From enrollment to 10- year study completion
Secondary	Treatment complication	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	From enrollment to 10- year study completion

External Links

•   Research foundation's website