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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?

Syncope

Study Interventions

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.

Study Arms

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.

Study Status

Completed

Start Date: January 2012

Completed Date: July 2015

Phase: N/A

Type: Observational

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01509534

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