MedTrace Logo

Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

NCT01621464 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2014-04-14

No results posted yet for this study

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.

Conditions

  • Syncope, Vasovagal

Interventions

DEVICE

Pacemaker with Closed Loop Stimulation (CLS sensor)

Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    collaborator INDUSTRY

  • Spanish Society of Cardiology

    lead OTHER

Principal Investigators

  • Gonzalo Barón Esquivias, MD PhD FESC · Spanish Society of Cardiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01621464 on ClinicalTrials.gov