Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT00120094
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
* Steal syndrome.
* 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;
* Pregnancy.
* Life expectancy \< 1 year due to non-cardiac cause
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Study:
NCT00120094
Study Brief:
Protocol Section:
NCT00120094