Approximately half of patients who present to hospital with syncope are discharged without a clear diagnosis. These patients with unexplained syncope are at increased risk of recurrent syncope and resultant serious injury.
Our research group has developed a risk score (the ‘DROP’ score) to predict which patients with unexplained syncope are most likely to benefit from a pacemaker to prevent further syncope. The DROP score is a simple tool which takes into account clinical and ECG features to generate a score from 0–4.
The Syncope-Stopper study is a multicentre, prospective randomised controlled trial. We will recruit patient presenting to hospital with unexplained syncope and a high risk score (DROP score ≥2). These participants will be randomized to receive upfront implantation of a pacemaker or conservative care without direct pacemaker implant: either Holter monitoring or insertion of an implantable loop recorder. Patients will be followed up for 12 months after enrollment. The primary outcome of the study will be a composite of cardiovascular death, recurrent syncope, bradycardia resulting in pacemaker implantation or device-related complications at 12-months.
Our hypothesis is that the novel DROP score will successfully identify patients at highest risk of bradycardia, and that early pacemaker implantation will be the safest and most cost-effective strategy for managing these patients.