ISSUE3: International Study on Syncope of Uncertain Etiology 3 (NCT00359203) | Clinical Trial Compass
CompletedPhase 4
ISSUE3: International Study on Syncope of Uncertain Etiology 3
Italy511 participantsStarted 2006-09
Plain-language summary
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.
Who can participate
Age range40 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Suspected or certain neurally-mediated syncope, based on the Guidelines recently published by the Task Force on Syncope of the European Society of Cardiology 2,3 (Appendix 1);
* More than 3 syncope episodes in the last 2 years;
* Clinical presentation of syncope of sufficient severity requiring treatment initiation in the physician's and patient's judgement.
* Age \> 40 years.
* Negative carotid sinus massage.
* Patients accept to have an ILR implantation.
Exclusion criteria:
* Carotid sinus hypersensitivity
* Suspected or certain heart disease and high likelihood of 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);
* Subclavian steal syndrome;
* Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator;
* Patient compliance doubtful;
* Patient geographically or otherwise inaccessible for follow-up;
* Patient unwilling or unable to give informed consent;
* Life expectancy \<1 year.