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Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting (PIAAF-FP)

Population Health Research Institute (PHRI) logo

Population Health Research Institute (PHRI)

Status

Completed

Conditions

Atrial Fibrillation

Treatments

Other: 30 Second Pulse Check
Device: Watch BP Home A
Device: HeartCheck Hand-held ECG device

Study type

Interventional

Funder types

Other

Identifiers

NCT02262351
PIAAF-FP

Details and patient eligibility

About

Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.

Full description

Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.

Enrollment

2,174 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age ≥65 years.
  2. Attending their usual Primary Care Clinic.
  3. Provide written informed consent.

Exclusion criteria

  1. Patients considered by the Investigator to be unsuitable for study follow-up because the patient:

    1. is unreliable concerning the follow-up schedule
    2. cannot be contacted by telephone
    3. has a life expectancy less than the anticipated study duration due to concomitant disease.
  2. Presence of an implanted pacemaker or defibrillator.

  3. Inability to have a BP cuff applied.

  4. Documented significant allergy to ECG electrode adhesive.

  5. Previously screened as part of this study.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2,174 participants in 1 patient group

Screening
Experimental group
Description:
Subjects will undergo three screening methods for atrial fibrillation: 30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
Treatment:
Device: HeartCheck Hand-held ECG device
Other: 30 Second Pulse Check
Device: Watch BP Home A

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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