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NCT Number: NCT05978466

MANAGE-AF Registry -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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence of Atrial fibrillation

    Time frame: From enrollment to 10- year study completion

    The natural progression of the condition will be assessed per medical record review

  2. Number of participants who had thrombo-embolic event

    Time frame: From enrollment to 10- year study completion

    All strokes, transient ischemic and systemic thrombo-embolic events

  3. Mortality

    Time frame: From enrollment to 10- year study completion

    All cause death will be noted

Secondary outcomes

  1. Number of participants who have experienced bleeding

    Time frame: 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

  2. Number of patients who have had pro-arrhythmia events

    Time frame: From enrollment to 10- year study completion

    All pro-arrhythmic events will be documented and assessed

  3. Number of patients who have had patient adherence events

    Time frame: 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

  4. Treatment complication

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Edward M Burke

CONTACT

[email protected]

773-432-4888

Martin C Burke, DO

CONTACT

[email protected]

773-432-4888

Sponsors and collaborators

Lead sponsor

CorVita Science Foundation

Other

Registry information

Official study title

MANAGEment of Atrial Fibrillation Outcomes Registry (MANAGE-AF)

Acronym: MANAGE-AF

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Aug 7, 2023
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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