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Completed

NCT Number: NCT02401854

Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder

The ASSERT-III study aims to determine the incidence of sub-clinical (silent) atrial fibrillation (AF) among elderly patients with hypertension and at least one other risk factor for AF. This will be accomplished by monitoring with a wireless external loop monitor for 30 to 60 days.

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Key information

Conditions

Elderly Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Hypertension Pathologic Processes Pathological Conditions, Signs and Symptoms Risk Factors for Atrial Fibrillation Vascular Diseases

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AVIVA Medical Diagnostics and Specialist Clinic Inc., Burlington, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients will be eligible for inclusion if they meet all of the following:

  • Age ≥ 80 years
  • History of hypertension OR a blood pressure of ≥ 140/90 mmHg
  • Attending a primary care clinic, OR ambulatory resident of a chronic care facility
  • At least one of the following additional risk factors for developing AF:
  • Diabetes
  • Body mass index ≥ 30
  • History of smoking
  • Documented Obstructive sleep apnea
  • Cardiovascular disease
  • Heart Failure
  • Left ventricular hypertrophy (on ECG or echocardiography)
  • Provide written informed consent

Exclusion criteria

  • ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes
  • Existing implanted pacemaker or defibrillator
  • Patients considered by the investigator to be unsuitable for study follow-up because the patient:
  • is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder
  • has a life expectancy less that the expected study duration due to concomitant disease
  • has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -

Treatment and study plan

Primary outcomes

  1. Occurance of atrial fibrillation episode

    Time frame: within 30 - 60 days of follow-up

    Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration

Secondary outcomes

  1. Tolerability and feasibility of long term monitoring in elderly patients

    Time frame: 30 - 60 days of follow-up

    The tolerability of long-term monitoring in elderly patients and the ability of these patients to manually transmit data to the cardiac analyses centre.

  2. Proportion of patients eligible to receive anticoagulation

    Time frame: 30 - 60 days of follow-up

  3. AF Burden

    Time frame: 30 - 60 days of follow-up

    An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF.

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Bristol-Myers Squibb
  • M-Health Solutions
  • Pfizer

Registry information

Official study title

Prevalence of Sub-Clinical Atrial Fibrillation in Elderly Patients With Hypertension, Detected Using an External Loop Recorder Using Automatic Algorithms for AF Detection: A Pilot Study (ASSERT-III)

Acronym: ASSERT-III

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Jun 4, 2025

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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