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Status:

TERMINATED

International Study on Syncope of Uncertain Etiology

Lead Sponsor:

Azienda USL Reggio Emilia - IRCCS

Collaborating Sponsors:

Medtronic

Conditions:

Syncope

Eligibility:

All Genders

30+ years

Brief Summary

This is a multi-center, prospective, observational study enrolling 400 patients with suspected or certain neurally-mediated syncope, who undergo carotid sinus massage, tilt testing and Implantable Loo...

Detailed Description

Study purpose was to verify the value of an Implanted Loop Recorder (ILR) in assessing the mechanism of syncope and the efficacy of ILR-guided therapy after documentation of syncope recurrence in pati...

Eligibility Criteria

Inclusion

  • Suspected or certain neurally-mediated syncope, based on the Guidelines of the ESC TF on Syncope.
  • 3 syncope episodes in the last 2 years.
  • Severe clinical presentation of syncope requiring treatment initiation in the judgement of the investigator.
  • Age \>30 years.
  • Patients have undergone carotid sinus massage, and ILR implantation.

Exclusion

  • ILR not implanted for any reason; in this case, the patients are still followed in the ILR-not implanted group.
  • Carotid sinus syndrome.
  • Suspected or certain 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).
  • Steal syndrome.
  • Psychologically or physically (due to any other illness) unfit for participation in the study according to the opinion of the investigator.
  • Patient compliance doubtful.
  • Patients who are geographically or otherwise inaccessible for follow-up.
  • Patient unwilling or unable to give informed consent;
  • Pregnancy.
  • Life expectancy \< 1 year due to non-cardiac cause

Key Trial Info

Start Date :

June 1 2002

Trial Type :

OBSERVATIONAL

End Date :

June 1 2005

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT00120094

Start Date

June 1 2002

End Date

June 1 2005

Last Update

April 11 2006

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Department of Cardiology, Arrhythmologic Centre

Lavagna, Genova, Italy, 16033

2

Arcispedale S Maria Nuova

Reggio Emilia, Reggio Emilia, Italy

3

Royal Brompton Hospital

London SW3 6NP, United Kingdom