To assess the effectiveness of pacing therapy for preventing syncope recurrence inpatients with a high probability of neurally-mediated syncope different from carotid sinus syndrome.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end-point:
- The time to first syncope recurrence.
Secondary outcome
Secondary end-points:
· ILR findings at the time of syncopal recurrence in the control group
(reproducibility of responses), and
· predictive value of tilt testing.
Background summary
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 recurrence rate from 33%
rate before implant (ILR phase 1) to 5% rate after implant (phase 2). Moreover,
the control non-asystolic group still continued to have a 41% recurrence rate
after the first recurrence of syncope, thus supporting the conclusion that the
reduction with pacemaker was due to the beneficial effect of pacemaker itself
and not to other factors. However a formal controlled trial is needed to
confirm these findings.
Study objective
To assess the effectiveness of pacing therapy for preventing syncope recurrence
in
patients with a high probability of neurally-mediated syncope different from
carotid sinus syndrome.
Study design
ISSUE 3 is a multi-center, prospective, randomised, double-blind study
evaluating the effectiveness of pacing therapy for preventing syncope
recurrence in patients with documented spontaneous asystolic neurally-mediated
syncope. The patients
undergoing randomisation are identified by ILR diagnostic observations among
patients who met the ESC criteria for a diagnosis of suspected
neurally-mediated syncope. The strategy requires early application of an ILR,
irrespective of tilt testing results (phase 1), and delay of therapy until
after ILR documentation of occurrence of an asystolic neurallymediated episode
(phase 2)
Intervention
Implantation of Reveal Plus (insertable loop recorder) and possibly
implantation of a pacemaker with first doucmented syncope.
Study burden and risks
No additional risks.
In phase I and in phase II the patient is expected to visit the hospital every
3 months, with a maximum duration of 2 years.
In phase I Reveal Plus will be implanted. In phase II the patient might be
implanted with a pacemaker.
Both implantations are standard procedures.
P.O. Box 5227
6802 EE
NL
P.O. Box 5227
6802 EE
NL
Listed location countries
Age
Inclusion criteria
- Suspected or certain neurally-mediated syncope.
- >3 Syncope episodes in the last 2 years
- Clinical presentation of syncope of sufficient severity requiring treatment initiation in the physician and patient's justment
- Age > 40 year
- Negative caroatid sinus massage
Exclusion criteria
- Carotid sinus hypersensitivity
· Suspected or certain heart disease and high likelihood of cardiac syncope:
- Syncope during exercise;
- Overt heart failure
- Ejection fraction > 40%;
- Old or recent myocardial infarction;
- Hypertrophic cardiomyopathy;
- Dilated cardiomyopathy;
- Significant valvular disease;
- Sinus bradycardia < 50 bpm or sino-atrial block;
- Mobitz I second degree atrioventricular block;
- Mobitz II 2nd or 3rd degree atrioventricular block;
- Bundle branch block;
- Rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
- Pre-excited QRS complexes
- Prolonged QT interval
- Right bundle branch block pattern with ST-elevation in leads V1-V3 (Brugada
syndrome)
- Negative T waves in right precordial leads, epsilon waves and ventricular late
potentials suggestive of arrhythmogenic right ventricular dysplasia.
· 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;
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT00120094 |
| CCMO | NL14040.018.06 |