RecruitingNot ApplicableNCT07459478
Assesment of the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
Multicenter RCT to Assess the Clinical Benefit of Provocation on Tilt-table in SYNCope Patients, TiltSYNC-trial
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
238 participants
Start Date
Oct 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Min Age: 18 Years
Inclusion Criteria1
- All patients \>18 years of age with certain/highly likely vasovagal syncope after the guideline based syncope evaluation
Exclusion Criteria7
- 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
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Interventions
DIAGNOSTIC_TESTbiofeedback and standard of care with tilt table testing
tilt table testing
DIAGNOSTIC_TESTno tilt table testing
only biofeedback, no tilt table testing
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07459478