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

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