Phase 4
N=77
ISSUE3: International Study on Syncope of Uncertain Etiology 3
Syncope
Bottom Line
View on ClinicalTrials.gov: NCT00359203 ↗Enrolled (actual)
77
Serious AEs
7.8%
Results posted
Nov 2013
Primary outcome: Primary: Syncope Recurrence Rate — 57; 25 percentage of participants — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dual chamber pacemeker (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Syncope Recurrence Rate |
57; 25 | 0.04 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00359203). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.