Status:
COMPLETED
Guideline-based Pacing Therapy for Reflex Syncope
Lead Sponsor:
Gruppo Italiano Multidisciplinare per lo Studio della Sincope
Conditions:
Syncope
Eligibility:
All Genders
40+ years
Brief Summary
Study hypothesis: Dual-chamber pacemaker therapy with rate-hysteresis features is effective in preventing syncopal recurrences in patients affected by cardioinhibitory (CI) forms of reflex syncope dia...
Detailed Description
Background Divergence of opinion exists regarding the efficacy of cardiac pacing in patients affected by different forms of reflex syncope. Definitions. Severe syncope is defined when: * it is perc...
Eligibility Criteria
Inclusion
- Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years.
Exclusion
- Reflex syncopes due to reversible causes, e.g., vasoactive drugs, concomitant diseases, etc
- Suspected of certain cardiac syncope
- Syncope caused by orthostatic hypotension
- Non-syncopal causes of transient loss of consciousness
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT01509534
Start Date
January 1 2012
End Date
July 1 2015
Last Update
July 29 2015
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Ospedale Generale Regionale
Bolzano, Italy
2
AO di Rilievo Nazionale e di Alta Specializzazione Garibaldi
Catania, Italy
3
PO S. Giuseppe
Empoli, Italy
4
AO Careggi
Florence, Italy