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

Syncope is very common and has a broad differential diagnosis. The diagnosis reflex syncope, orthostatic hypotension, POTS or psychogenic syncope rely mainly on the initial syncope evaluation that consists of history taking, physical examination (including supine and standing blood pressure measurement) and ECG (class I, Level C). Besides the initial evaluation for the diagnosis also reassurance, explanation and education with biofeedback on life style measures is an important part of standard care and treatment of these patients (class 1, level B). In the current guidelines on syncope, provocation on tilt table testing should be considered in patients with suspected reflex syncope (Class IIb, Level B). For vasovagal syncope, which is a form of reflex syncope, tilt table testing has become a widely accepted tool in the work up and treatment, however evidence for this is lacking so far. In current medical practice there is a true equipoise for the use of provocation on tilt table in these patients. A randomized controlled trial to compare the standard of care without tilt table test versus standard of care with tilt table test in patients with certain/highly likely vasovagal syncope has never been done so far.

Inclusion Criteria:

• All patients >18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation

Exclusion Criteria:

• 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
• Those presenting with pre-syncope and not with complete loss of consciousness
• Those who are unwilling to provide informed consent
• Those already diagnosed prior to evaluation who are referred for specific treatment op-tions