SAFE PACE 2: Syncope and Falls in the Elderly--Pacing and Carotid Sinus Evaluation: a randomized controlled trial of cardiac pacing in older patients with falls and carotid sinus hypersensitivity

Abstract

SAFE PACE is a multicentre randomized controlled trial to assess the efficacy of dual-chamber pacing in older patients with carotid sinus hypersensitivity and recurrent unexplained falls. Patients are eligible if they have had two or more unexplained falls (+/- up to one syncope) and if they have a cardio-inhibitory response (>3 s asystole) to carotid sinus massage. Patients will be randomized to receive either a Medtronic Kappa 700(Europe)/Kappa 400(North America) pacemaker or an implantable loop recorder (ILR)(control group). Patients will be required to complete weekly fall diaries. The primary outcome measure is the number of patients who fall in the 24-month follow-up period. Recruitment began in October 1998 and continues for 12 months; the follow-up is for 24 months.