Guideline-based Pacing Therapy for Reflex Syncope (SUP2)
|ClinicalTrials.gov Identifier: NCT01509534|
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : July 29, 2015
|Condition or disease|
Background Divergence of opinion exists regarding the efficacy of cardiac pacing in patients affected by different forms of reflex syncope.
Severe syncope is defined when:
- it is perceived by patient that it alters his/her quality of life, and
- is unpredictable because occurs without, or with very short prodromes < 10 sec (thus exposing patients to risk of trauma) or, if preceded by prodromes, syncope recurs despite appropriate therapies (CPM or drugs).
Recurrent syncopes: at least 2 episodes during the last year (including the index episode) or 3 episodes during the last 2 years (including the index episode).
Suspected (undetermined) reflex syncope: the suspicion of reflex syncope is based on a history of uncertain syncope in the absence of (i) severe structural heart disease, significant ECG abnormalities, or rhythm disturbances; (ii) orthostatic hypotension; and (iii) non-syncopal causes of transient loss of consciousness.
- The eligible patients undergo firstly carotid sinus massage (according to the method of symptoms); if a diagnosis of cardioinhibitory carotid sinus syndrome (CI-CSS) is made, a pacemaker is implanted and follow-up immediately starts.
- If the carotid sinus massage is negative or vasodepressor, the patients undergo tilt table testing (with nitroglycerin or clomipramine drug challenge); if a diagnosis of VASIS 2B form is made, a pacemaker is implanted and follow-up immediately starts.
- If tilt table testing is negative or a form different from VASIS 2B is induced, the patients undergo ILR implantation. If a diagnosis of asystolic reflex syncope is made, a pacemaker is implanted and follow-up immediately starts.
End-points End-point of the study is syncope recurrence after pacemaker (PM) implantation. Syncope is defined as complete transient loss of consciousness. Pre-syncope is counted but it is not an end-point.
- Comparison of the time to first syncopal recurrence in CI-CSS and CI-TTT pts with PM and in control patients with ILR.
- Intra-patient comparison of the syncope burden in the year before and in the year following PM implant in all patients receiving a PM (CCS, TTT and ILR groups). Index syncope is not counted.
Follow-up One year after PM implantation for all enrolled patients for burden of syncope end-points Until the study end for time to first syncope recurrence end-points. Thus, the study ends one year after the enrollment of the last patient.
Study size Based on the sample size calculation the study will stop when 700 patients are enrolled.
|Study Type :||Observational|
|Actual Enrollment :||281 participants|
|Official Title:||Guideline-based Pacing Therapy for Reflex Syncope|
|Study Start Date :||January 2012|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
- syncope recurrence after PM implantation [ Time Frame: 1 year ]
- syncope burden after PM implantation [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509534
|Ospedale Generale Regionale|
|AO di Rilievo Nazionale e di Alta Specializzazione Garibaldi|
|PO S. Giuseppe|
|Nuovo Ospedale S. Giovanni di Dio|
|Department of Cardiology, Ospedali del Tigullio|
|Lavagna, Italy, 16033|
|Arcispedale S. Maria Nuova|
|Reggio Emilia, Italy|
|Ospedale SS. Annunziata|
|Principal Investigator:||Michele Brignole, MD||Ospedali del Tigullio, Lavagna, Italy|