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Research

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ASSERT

Official Title

Asymptomatic Atrial Fibrillation and Stroke Evaluation in Pacemaker Patients and the Atrial Fibrillation Reduction Atrial Pacing Trial

Status

Completed

Overview

To evaluate the hypothesis among patients with a standard indication for pacing and no previous history of AF, detection of AHRE predicts an increased risk of stroke and systemic embolism. The second hypothesis to be tested is that overdrive atrial pacing with the AF suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.

Study Design

Randomized, multicenter, cohort follow-up, and single-blinded trial of atrial overdrive pacing in elderly hypertensive patients with a pacemaker recently implanted for sinus or atrioventricular (AV) node disease.

Primary Endpoint

Primary Outcomes: Asymptomatic AF Stroke Evaluation, first occurance of either component of the composite of 1. Ischemic Stroke 2. Non-CNS systemic embolism. Trial of AF Suppression Algorithm, Symptomatic or asymptomatic atrial tachyarrhythmia (>6mins) documented by 12 lead ECG, or surface ECG rhythm strip. Secondary Outcomes: 1. Symptomatic atrial tachyarrhythmia (>6mins) documented by 12 lead ECG, or surface ECG rhythm strip. 2. Symptomatic or asymptomatic atrial tachyarrhythmia (>6mins) documented by 12 lead ECG, surface ECG rhythm strip or pacemaker telemetry (EGMs only). 3. Total cardiovascular events (composite of stroke, myocardial infarction, vascular death, systemic embolism or admission to hospital for heart failure). 4. AF Burden as derived from the pacemaker telemetry. 5. Major bleed.

Number of Patients

2580

Number of Sites

136

Number of Countries

23

Study Period

2007–2011

Principal Investigator

Stuart Connolly, Jeff Healey

Program Manager

Ellison Themeles

Research Coordinator

Not Applicable

Collaborators

St. Jude Medical

Key Publications

  • Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJV, Michelson EL, Olofsson B, Ostergren J, Yusuf S for the CHARM Investigators and Committees. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall Programme. Lancet 2003; 362: 759-66

  • McMurray JJV, Ostergren J, Swedberg K, Granger CB, Held P, Michelson EL, Olofsson B, Yusuf S, Pfeffer MA for the CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and reduced left ventricular systolic function treated with an ACE-inhibitor: the CHARM-Added trial. Lancet 2003; 362: 767-71.

  • Granger CB, McMurray JJV, Yusuf S, Held P, Michelson EL, Olofsson B, Ostergren J, Pfeffer MA, Swedberg K, for the CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and reduced left ventricular systolic function and intolerant to ACE inhibitors: the CHARM-Alternative Trial. Lancet 2003; 362: 772-76.

  • Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJV, Michelson EL, Olofsson B, and Ostergren J for the CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left ventricular systolic function: the CHARM-Preserved trial. Lancet 2003; 362: 777-81.