Status:
COMPLETED
ISSUE3: International Study on Syncope of Uncertain Etiology 3
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Syncope
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief 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.
Detailed Description
In asystolic neurally-mediated syncope (NMS) documented by Implantable Loop recorder (ILR), ISSUE-2, an observational trial, showed that pacemaker was effective in reducing the 1-year first syncope re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT00359203
Start Date
September 1 2006
End Date
November 1 2012
Last Update
July 18 2025
Active Locations (1)
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1
Medtronic Italia S.p.A.
Rome, Italy, 00165