completed

In the ASSERT study, subclinical Atrial Fibrillation (SCAF) 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 were invited to participate in the ASSERT III study where they were monitored over a 60-day period for the development of subclinical AF via an external loop recorder. The device automatically recorded and transmitted ECGs through a BlackBerry Smartphone.

The primary hypothesis was 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 Type

Interventional - Device

Study Design

Cohort study

NO. of Countries

1

NO. of Sites

8

NO. of Participants

129

Study Period

2014 - 2015

Sponsor

PHRI

Bristol-Myers Squibb

NIF

BMS/Pfizer grant-in-aid

m-Health Solutions grant-in-aid

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