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Photo for ASSERT III

ASSERT III

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: (ASSERT-III)

Status

Ongoing

Overview

In the ASSERT study, subclinical Atrial Fibrillation (AF) detected by a pacemaker over a prolonged period of time was shown to increase a patient’s risk of stroke by almost 3-fold. Less evasive techniques using external loop recorders now affords the possibility for longer term monitoring and the possibility of diagnosing a substantial portion of this sub-clinical AF. Patients most at risk for developing AF are those who are elderly and have a history of hypertension. These patients will be invited to participate in the ASSERT III study where they will be monitored over a 60 day period for the development of subclinical AF via an external loop recorder. The device will automatically record and transmit ECGs through a BlackBerry Smartphone. The primary hypothesis is that among this elderly population with hypertension and a least one other risk factor for AF, the monitoring will detect AF in at least 10% of patients who would be potential candidates for anticoagulant therapy.

Study Design

Cohort study – Patients from the ASSERT study will be invited to participate in the ASSERT III study where they will be monitored over a 60 day period for the development of subclinical AF via an external loop recorder.

Primary Endpoint

Time to AF, Prevalence of AF, Tolerability of long term monitoring, Proportion of patients who receive anticoagulation therapy, Cost-effectiveness of prolonged external loop monitoring as a strategy for stroke prevention, Burden of atrial arrhythmias in patients with AF, Prevalence of AF episodes of at least 30 seconds.

Number of Patients

150

Number of Sites

15

Number of Countries

1

Study Period

2014–2015

Principal Investigator

Stuart Connolly, Jeff Healey

Program Manager

Kimberly Begley

Research Coordinator

Kim Simek