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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT01814228
Eligibility Criteria:
Twenty consecutive patients affected by cardioinhibitory neurocardiogenic syncope will be enrolled in the study.
Inclusion criteria:
* age between 18 and 60 years
* 3 syncopal episodes at least of likely CNS in the previous 2 years
* marked cardioinhibitory response to HUT or documented asystolic pauses at internal loop recorder registration \[7\].
Cardioinhibition will be considered as elicitation of asystolic pause (sinus arrest or AV block) ≥ 3 seconds associated to syncope or ≥ 6 seconds and related presyncope.
Exclusion criteria:
* documented myocardial and/or valvular abnormalities on 2D echocardiogram (ejection fraction lower than 50%)
* documented tachyarrhythmias as possible causes of symptoms
* channelopathies (Brugada syndrome, LQT or SQT syndrome)
* ventricular preexcitation
* symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement
* pregnancy in women
* previous cardiac pacemaker implantation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01814228
Study Brief:
Protocol Section:
NCT01814228