multicenter prospective randomized controlled comparison of biofeedback with tilt table testing (investigational management strategy) vs biofeedback without tilt table testing (reference management strategy) in patients with certain/highly likely vasovagal syncope
All patients >18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation
Those aged <18 years
Any patient diagnosed with another form of reflex syncope other than vasovagal syn-cope
Contraindication for tilt table testing at the discretion of the responsible physician
Those with a learning disability
Parallel
biofeedback and standard of care with tilt table testing
Diagnostic testtilt table testing
no tilt table testing
Diagnostic testonly biofeedback, no tilt table testing
Syncope recurrence rate
The rate of syncope recurrence
Time till first syncope
Time till the first syncope after tilt-table testing
Near-syncope recurrence rate
Amount of near-syncopal events
Health Technology Assesment
Amount of made healthcare costs
Quality of life
Quality of life using: SF-12: Short-form 12: higher scores indicate a better quality of life. Scores are transformed using standardized transformation. Mean score 50; population score mean / mean score 40 or 60 equals a 1SD deviation from the mean population score. SDF: Syncope daily function: higher scores are better daily functioning Minimal score 16, maximum score 51
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