At a glance
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Effect of Pacemaker With Closed Loop Sensor on Quality of Life and Recurrence of Syncope in Patients With Neuromodulated Syncope Refractory to Medical Treatment: Randomized Double-blind Clinical Trial
In Brief
A clinical study evaluating Pacemaker with Closed Loop Stimulation (CLS) for Syncope. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
Vasovagal syncope is an entity frequently in the emergency services, its treatment includes pharmacological and non-pharmacological measures, and in some severe cases, requires the implantation of cardiac stimulation devices, specifically, those pacemakers that have closed-loop sensors (CLS). This research is an intervention study, multi-institutional, randomized and double blind that will be carried out in patients older than 18 years, with a diagnosis of neurally mediated type 1, 2A or 2B syncope documented in a tilting table test, who have had at least 2 syncope in the last year and that significantly affects the quality of life despite the use of pharmacological and non-pharmacological non-interventionist therapy. This study aims to evaluate the effect of cardiac pacing therapy with CLS pacemakers on quality of life, recurrence of syncope and pre-syncopal symptoms in patients with a diagnosis of neurally mediated syncope in this group of patients.
Study Details
Timeline
Interventions
In active mode of closed loop sensor (CLS), evaluate its impact on quality of life and recurrence of syncope.