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

C

CorVita Science Foundation

Status

Enrolling

Conditions

Atrial Fibrillation

Study type

Observational

Funder types

Other

Identifiers

NCT05978466
2017-CSF-00100

Details and patient eligibility

About

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.

Full 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

Enrollment

1,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Martin C Burke, DO; Edward M Burke

Data sourced from clinicaltrials.gov

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