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 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT02324920
Eligibility Criteria:
Inclusion Criteria:
Patients affected by clinical diagnosis of reflex syncope who meet all the following criteria:
* age \>=40 years
* significant limitation of social and working life due to unpredictable or frequent syncope recurrences, ≥2 within the last year.
* type 2B cardio-inhibitory response to TT (according to the VASIS classification).
* Alternative therapies have failed or were not feasible.
* exclusion of other possible competitive causes of syncope.
Exclusion Criteria:
\- Any other indication to IPG, implantable defibrillator (ICD), cardiac resynchronization therapy (CRT), according to current guidelines
Any cardiac dysfunctions possibly leading to loss of consciousness:
* overt heart failure;
* ejection fraction (LVEF) \<40% (Echo-assessed within 3-month prior to study participation);
* myocardial infarction;
* diagnosis of hypertrophic or dilated cardiomyopathy;
* clinically significant valvular disease;
* sinus bradycardia \<50 bpm or sinoatrial block;
* Mobitz I second-degree atrioventricular block;
* Mobitz II second or third-degree atrioventricular block;
* bundle-branch block;
* rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
* preexcited QRS complexes;
* prolonged QT interval;
* Brugada syndrome;
* arrhythmogenic right ventricular cardiomyopathy
* Symptomatic orthostatic hypotension diagnosed by standing BP measurement;
* Nonsyncopal loss of consciousness (eg, epilepsy, psychiatric, metabolic, drop-attack, cerebral transient ischemic attack, intoxication, cataplexy).
* Symptomatic cardioinhibitory carotid sinus hypersensitivity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT02324920
Study Brief:
Protocol Section:
NCT02324920