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

NCT ID: NCT05978466

Last Updated: 2024-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-22

Study Completion Date

2027-12-31

Brief Summary

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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

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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

Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CorVita Science Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin C Burke, DO

Role: PRINCIPAL_INVESTIGATOR

Chief Scientific Officer

Locations

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CorVita Science Foundation (NFP)

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Edward M Burke

Role: CONTACT

773-432-4888

Martin C Burke, DO

Role: CONTACT

773-432-4888

Facility Contacts

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Edward Burke

Role: primary

773-432-4888

Martin C Burke, DO

Role: backup

773-432-4888

Related Links

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http://www.corvitascience.org

Research foundation's website

Other Identifiers

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2017-CSF-00100

Identifier Type: -

Identifier Source: org_study_id

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