GLOBAL HEALTH | GLOBAL PARTNERSHIPS | GLOBAL IMPACT

Research

Photo for ASSERT II

ASSERT II

Official Title

Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor in Patient with Cardiovascular Risk Factors (ASSERT-II)

Status

Ongoing

Overview

Patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF will have a continuous ECG monitor implanted (St. Jude Medical Confirm® Implantable Cardiac Monitor) to detect the incidence of sub-clinical AF and study the relationship between sub-clinical AF and left atrial volume and other potential predictors. Patients will be recruited from a variety of clinical settings (HF clinics, stroke clinics, diabetes clinics, pre-op and pre-catheterization clinics) and in many cases the implant can be done in conjunction with a planned surgery or procedure. All patients will be followed at 1, 3, 6 and 9 months and then undergo a final visit at 18 months of follow-up or after the last patient has been followed for 9 months (whichever comes first).

Study Design

Cohort study – Patients with known cardiovascular risk factors and left atrial enlargement, but without prior AF will have a continuous ECG monitor implanted (St. Jude Medical Confirm® Implantable Cardiac Monitor)

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

250

Number of Sites

30

Number of Countries

2

Study Period

2012-2016

Principal Investigator

Stuart Connolly, Jeff Healey, Marco Alings

Program Manager

Kimberly Begley

Research Coordinator

Kim Simek