Syncope-Stopper
The Syncope-Stopper study: comparison of the effectiveness and complications of upfront pacing with standard care for high-risk adult patients with unexplained syncope
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 200 older adults with high-risk unexplained syncope, upfront pacemaker implantation was compared with standard monitoring on cardiovascular death, recurrent syncope, bradycardia or device complications at 12 months.
N
200
Disegno
Australian multicentre, prospective, open-label, parallel-group randomised controlled trial (sponsor Alfred Health, Melbourne); randomisation to upfront permanent pacemaker implantation versus standard care without upfront pacing (Holter monitoring or implantable loop recorder as directed by the treating team); 3-monthly face-to-face visits with symptom questionnaire, ECG and postural BP; 12-month follow-up; first enrolment March 2023; patients with DROP score 0–1 followed in an additional observational arm.
Esito
12-month composite of cardiovascular death, recurrent syncope, bradycardia resulting in pacemaker implantation, or device-related complications