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

MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

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.

Study Overview

• Status: Recruiting
• Conditions: 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:

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Edward M Burke; Phone Number: 773-432-4888; Email: eddie@corvitahealth.org
• Study Contact Backup: Name: Martin C Burke, DO; Phone Number: 773-432-4888; Email: mburke@corvitahealth.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60605
      • Recruiting
      • CorVita Science Foundation (NFP)
      • Contact: Martin C Burke, DO; Phone Number: 773-432-4888; Email: mburke@corvitahealth.org
      • Contact: Edward Burke; Phone Number: 773-432-4888; Email: eddie@corvitahealth.org
      • Principal Investigator: Martin C Burke, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All subjects with the diagnosis of atrial fibrillation can be enrolled into the study regardless of sex, age or medical history

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: CorVita Science Foundation
• Investigators: Principal Investigator: Martin C Burke, DO, Chief Scientific officer

Publications and helpful links

Helpful Links

• Research foundation's website

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: stroke; atrial fibrillation; bleeding; atrial arrhythmia; Left Atrial Appendage Occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 2017-CSF-00100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to publish the results or outcomes associated with this registry to major peer-reviewed journals, didactic or poster sessions at national/international medical conferences.
• IPD Sharing Time Frame: Intermittently over the next 10-15 years
• IPD Sharing Access Criteria: Co-investigator who enrolls at least one patient
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No