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

NCT ID: NCT02401854

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Elderly Hypertension Risk Factors for Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 -
Minimum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

M-Health Solutions

UNKNOWN

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Jeff Healey

Co-Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeff Healey, M.D.

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Stuart Connolly, M.D.

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

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AVIVA Medical Diagnostics and Specialist Clinic Inc.

Burlington, Ontario, Canada

Site Status

Hamilton Medical Research Group

Hamilton, Ontario, Canada

Site Status

Family Practice - Drs. Cameron, Crombie & Croft

Hamilton, Ontario, Canada

Site Status

OakMed Family Health Team

Oakville, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ASSERT-III

Identifier Type: -

Identifier Source: org_study_id

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