Syncope | Guideline-based Pacing Therapy for Reflex Syncope
Syncope research study
What is the primary objective of this study?
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 diagnosed by means of carotid sinus massage, tilt table testing or implantable loop recorder (ILR). The outcome is measured either by the time to first syncopal recurrence or the total syncope burden.
Who is eligible to participate?
Inclusion Criteria: - Patients affected by severe, recurrent, certain or suspected (undetermined) reflex syncopes, aged ≥ 40 years. Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2012
Completed Date: July 2015
Primary Outcome: syncope recurrence after PM implantation
Secondary Outcome: syncope burden after PM implantation
Study sponsors, principal investigator, and references
Principal Investigator: Michele Brignole, MD
Lead Sponsor: Gruppo Italiano Multidisciplinare per lo Studio della Sincope