International Study on Syncope of Uncertain Etiology
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This is a multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and Implantable Loop Recorder (ILR)implantation. In its second phase, which starts after the first ILR-documented syncope, the study will register the patient outcome after administration of ILR-guided therapy, which is left to the discretion of the physicians. The main objective is to verify the value of ILR in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence.
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Ages Eligible for Study:
30 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF on Syncope.
3 syncope episodes in the last 2 years.
Severe clinical presentation of syncope requiring treatment initiation in the judgement of the investigator.
Age >30 years.
Patients have undergone carotid sinus massage, and ILR implantation.
ILR not implanted for any reason; in this case, the patients are still followed in the ILR-not implanted group.
Carotid sinus syndrome.
Suspected or certain cardiac syncope.
Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement.
Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy).
Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator.
Patient compliance doubtful.
Patients who are geographically or otherwise inaccessible for follow-up.
Patient unwilling or unable to give informed consent;