None listed
Conditions
Brief summary
The Syncope Stopper trial is a randomised controlled trial which will enroll patients hospitalised with unexplained syncope who have additional high risk features for recurrent syncope. Participants will be randomised 1:1 to either insertion of a permanent pacemaker or to standard care. Participants will be followed up for 12 months and will be assessed for the frequency of a composite primary endpoint comprising cardiovascular death, recurrent syncope, bradycardia resulting in pacemaker insertion or device-related complications. Our overall study hypothesis is that early pacemaker implantation (a ‘Syncope-Stopper’) is the safest and most cost-effective strategy for managing high-risk patients with unexplained syncope, with the novel DROP score able to identify patients at highest risk of bradycardia.
Interventions
The Syncope Stopper study is a randomised control trial which we aim to conduct in adults presenting with unexplained syncope and high risk features for recurrent syncope. We will randomise these patients to upfront pacemaker insertion vs standard care.
Participants randomised to pacemaker insertion will undergo implantation of a permanent pacemaker, completed by a cardiologist with expertise in cardiac pacing. Remaining participants will receive standard care as dictated by their cardiology o
The Syncope Stopper study is a randomised control trial which we aim to conduct in adults presenting with unexplained syncope and high risk features for recurrent syncope. We will randomise these patients to upfront pacemaker insertion vs standard care. Participants randomised to pacemaker insertion will undergo implantation of a permanent pacemaker, completed by a cardiologist with expertise in cardiac pacing. Remaining participants will receive standard care as dictated by their cardiology or general medical team. All participants will be followed up for 12 months. During this follow up period, 3 monthly assessment will be completed at face-to-face study visit, involving a symptom questionnaire, clinical examination, 12 lead ECG and postural blood pressure recording.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• At least 1 ‘unexplained’ syncopal episode within 1 year prior to enrollment • Age greater than or equal to 55 years; • DROP score greater than or equal to 2
Exclusion criteria
• Likely neurocardiogenic or vasovagal cause of syncope, defined as postural BP drop >30 mmHg, carotid sinus hypersensitivity, history of micturition, defecation or cough syncope) • Left ventricular ejection fraction <40% • Previous PPM, ICD, or ILR implant • Existing ACC/AHA/HRS/ESC Class I indication for PPM or ICD implantation • Contraindication to insertion of a transvenous cardiac pacing device • Comorbidity precluding 12 months follow-up • DROP score 0-1: these patients will be monitored in an additional observational arm
Outcome results
None listed