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International Study on Syncope of Uncertain Etiology

NCT00120094 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2006-04-11

No results posted yet for this study

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 Loop Recorder (ILR)implantation. In its second phase, which starts after the first ILR-documented syncope, the study will register the patient outcome after administration of ILR-guided therapy, which is left to the discretion of the physicians. The main objective is to verify the value of ILR in assessing the mechanism of syncope and the efficacy of the ILR-guided therapy after syncope recurrence.

Conditions

  • Syncope

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Azienda USL Reggio Emilia - IRCCS

    lead OTHER_GOV

Principal Investigators

  • Carlo Menozzi, MD · Department of Interventional Cardiology, Opsedle S Maria Nuova, Reggio Emilia

  • Michele Brignole, MD · Department of Cardiology, Arrhythmologic Centre, Ospedali del Tigullio, Lavagna

  • Richard Sutton, MD · Royal Brompton & National Heart Hospital, London

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-06-30
Completion
2005-06-30

Countries

  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120094 on ClinicalTrials.gov