AzTrials
AzTrials

ElderlyASSERT-IIINCT02401854

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

An observational study of Elderly and Hypertension, run by Population Health Research Institute at 4 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 80 years and older
How many people
129 participants
Where
4 sitesCanada
Study dates
Jan 2014to Mar 2015
How long will I take part?
60 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 80 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: elderly patients attending primary care clinic or ambulatory resident of a chronic care facility, with hypertension and at least one addional risk factor for developing AF.

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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 -

Trial locations and contacts

4 sites in 1 country.

Canada4 sites

  • AVIVA Medical Diagnostics and Specialist Clinic Inc.

    Burlington, Ontario, L7R 1E2

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8M 1K7

  • Family Practice - Drs. Cameron, Crombie & Croft

    Hamilton, Ontario

  • OakMed Family Health Team

    Oakville, Ontario, L6H 7S8

Other trials in Canada

About this study

Official 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)

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.

Keywords
atrial fibrillation, hypertension, risk factors, primary care, elderly
Medical subject headings
Hypertension, Atrial Fibrillation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurance of atrial fibrillation episode

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

    Measured: within 30 - 60 days of follow-up

Secondary outcomes (3)

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

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

    Measured: 30 - 60 days of follow-up

  2. Proportion of patients eligible to receive anticoagulation

    Measured: 30 - 60 days of follow-up

  3. AF Burden

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

    Measured: 30 - 60 days of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
129 participants (actual)
Target duration
60 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02401854
Sponsor's protocol ID
ASSERT-III
Acronym
ASSERT-III
Status last verified
Apr 2015
First submitted
3 Nov 2014
Last updated
4 Jun 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Elderly and Hypertension, run by Population Health Research Institute at 4 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurance of atrial fibrillation episode (time frame: within 30 - 60 days of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02401854.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in