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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02401854

Acronym

ASSERT-III

Enrollment

129

Registered

2015-03-30

Start date

2014-01-31

Completion date

2015-03-31

Last updated

2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Hypertension, Risk Factors for Atrial Fibrillation

Keywords

atrial fibrillation, hypertension, risk factors, primary care, elderly

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

80 Years to No maximum

Healthy volunteers

Inclusion criteria

Patients will be eligible for inclusion if they meet all of the following: 1. Age ≥ 80 years 2. History of hypertension OR a blood pressure of ≥ 140/90 mmHg 3. Attending a primary care clinic, OR ambulatory resident of a chronic care facility 4. At least one of the following additional risk factors for developing AF: 1. Diabetes 2. Body mass index ≥ 30 3. History of smoking 4. Documented Obstructive sleep apnea 5. Cardiovascular disease 6. Heart Failure 7. Left ventricular hypertrophy (on ECG or echocardiography) 5. Provide written informed consent

Exclusion criteria

1. ECG documented history of AF or atrial flutter, with an episode duration ≥ 6 minutes 2. Existing implanted pacemaker or defibrillator 3. Patients considered by the investigator to be unsuitable for study follow-up because the patient: 1. is unreliable concerning the requirements for follow-up during the study and/or compliance with the use of the external loop recorder 2. has a life expectancy less that the expected study duration due to concomitant disease 3. has a condition which in the opinion of the investigator, would not allow current chronic treatment with anticoagultion -

Design outcomes

Primary

Measure	Time frame	Description
Occurance of atrial fibrillation episode	within 30 - 60 days of follow-up	Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration

Secondary

Measure	Time frame	Description
Tolerability and feasibility of long term monitoring in elderly patients	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.
Proportion of patients eligible to receive anticoagulation	30 - 60 days of follow-up	—
AF Burden	30 - 60 days of follow-up	An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF.

Countries

Canada

Outcome results