Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older

Summary

Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring technologies have the potential to improve early detection of AF. This trial investigates AF screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home blood pressure monitor that has built-in AF screening capability.

Conditions

• Atrial Fibrillation
• Hypertension

Interventions

DEVICE

Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)

The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.

Sponsors & Collaborators

• Canadian Stroke Prevention Intervention Network

  collaborator OTHER

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Heart and Stroke Foundation of Canada

  collaborator OTHER

• Canadian Stroke Network

  collaborator OTHER

• iRhythm Technologies, Inc.

  collaborator INDUSTRY

• Microlife

  collaborator INDUSTRY

• University of Leipzig

  collaborator OTHER

• Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

  collaborator OTHER

• Population Health Research Institute

  lead OTHER

Principal Investigators

• David J. Gladstone, MD PhD FRCPC · Sunnybrook Research Institute, University of Toronto

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2015-04-01

Primary Completion

2019-10-21

Completion

2020-01-21

Countries

• Canada
• Germany

Study Locations