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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02401854
Other study ID # ASSERT-III
Secondary ID
Status Completed
Phase N/A
First received November 3, 2014
Last updated April 27, 2015
Start date January 2014
Est. completion date March 2015

Study information

Verified date April 2015
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Observational [Patient Registry]

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 129
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 80 Years and older
Eligibility 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 -

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Canada AVIVA Medical Diagnostics and Specialist Clinic Inc. Burlington Ontario
Canada Family Practice - Drs. Cameron, Crombie & Croft Hamilton Ontario
Canada Hamilton Medical Research Group Hamilton Ontario
Canada OakMed Family Health Team Oakville Ontario

Sponsors (4)

Lead Sponsor Collaborator
Population Health Research Institute Bristol-Myers Squibb, M-Health Solutions, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurance of atrial fibrillation episode Detection rate of sub-clinical atrial fibrillation episodes, at least 6 minutes in duration within 30 - 60 days of follow-up No
Secondary 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. 30 - 60 days of follow-up No
Secondary Proportion of patients eligible to receive anticoagulation 30 - 60 days of follow-up No
Secondary AF Burden An estimate of the burden of atrial arrhythmias (from device logs) in patients with AF. 30 - 60 days of follow-up No
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