Closed Loop Stimulation for Neuromediated Syncope

Spanish Society of Cardiology1 site in 1 country55 target enrollmentMay 2006

ConditionsSyncope, Vasovagal

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Syncope, Vasovagal
Sponsor: Spanish Society of Cardiology
Enrollment: 55
Locations: 1
Primary Endpoint: Reduction of number of syncopes
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Physiological stimulation therapy effectiveness will be proved with contractility sensor or CLS sensor (Closed Loop Stimulation), in BIOTRONIK CLS pacemakers to prevent from neuromediated syncope. Furthermore, not only will be investigated if this system eradicates syncopes, but also if the number of presyncopal episodes is reduced.

Registry

clinicaltrials.gov

Start Date

May 2006

End Date

January 2016

Last Updated

12 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Spanish Society of Cardiology

Responsible Party

Principal Investigator

Gonzalo Barón-Esquivias, MD, PhD, FESC

member of Syncope Working Group (within Section of Electrophysiology and Arrhythmias)

Spanish Society of Cardiology

Eligibility Criteria

Inclusion Criteria

•Patients that fulfill the requirements of the study:
•Patients with 5 previous neuromediated syncopes
•Positive Tilt test, Cardioinhibitory response, heart rate \< 40 bpm for at least 10'' or pauses \> 3''
•Patient ≥ 40 years
•No cardiopathy present
•Patients without the following contraindications:
•Drug treatment with β-blockers
•Chronic Polyneuropathy
•All contraindications for DDD or DDDR pacing (as per clinical guidelines SEC, 2002)
•Geographically stable patients and able to attend all follow ups

Exclusion Criteria

•Patients that do NOT fulfill the inclusion criteria mentioned above
•Patients with the contraindications indicated above
•Patients with syncopes due to Carotid Sinus Hypersensitivity
•Other syncope causes different to the CNS
•Patients involved in other clinical studies
•Pregnant women or in age bearing that are not using at least 2 contraception methods