Device: DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)
Boston Scientific Corporation
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Combined endpoint defined as first occurrence among the following events 1)Syncope episode of any origin; 2)Presyncopal episode with documented cardioinhibitory origin 3) Atrioventricular block of any degree associated with patient symptoms
Occurrence of first symptomatic episode (syncope or pre-syncope), independently from origin.
18 Years and older (Adult, Senior)
November 1, 2011
January 6, 2016
Ospedale Santa Maria Annunziata Bagno a Ripoli, Italy
Azienda Ospedaliera S. Sebastiano Caserta, Italy
Ospedale Valduce Como, Italy
(and 9 more...)
† Study has passed its completion date and status has not been verified in more than two years.