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NCT03876652

Pacemaker Effect With Closed Loop Sensor in Neuromodulated Syncope Refractory to Medical Therapy

Completed NA Last updated 9 March 2022
What this trial tests

NA trial testing Pacemaker with Closed Loop Stimulation (CLS) in Syncope in 48 participants. Completed in 1 March 2022.

Timeline
22 November 2017
Primary endpoint
15 April 2021
1 March 2022

Quick facts

Lead sponsorCES University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment48
Start date22 November 2017
Primary completion15 April 2021
Estimated completion1 March 2022
Sites2 locations across Colombia

Drugs / interventions tested

Conditions studied

Sponsor

CES University

Who can join

18 and older, any sex, with Syncope. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Syncope

Currently open trials in the same condition.

Other CES University trials

Trials by the same sponsor.

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Data sources for this page

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