NCT01621464|UnknownPhase 4
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
SPAIN
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SPAIN
Sponsor study identifier
interventional
55
1 country
1
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 11, 2012
Actual (reported)June 18, 2012
Actual (reported)January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Reduction of number of syncopes
Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope
1 year
Time reduction to the first syncope
1 year
Reduction of the recurrence of presyncopal symptoms
1 year
Improvement of Quality of Life
1 year
Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)
pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)
Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013, Spain
Baron-Esquivias G, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R, Morillo CA. Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study. Europace. 2020 Feb 1;22(2):314-319. doi: 10.1093/europace/euz294.
Baron-Esquivias G, Morillo CA, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R. Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study. J Am Coll Cardiol. 2017 Oct 3;70(14):1720-1728. doi: 10.1016/j.jacc.2017.08.026.
Gonzalo Barón Esquivias, MD PhD FESC
Spanish Society of Cardiology
First Submitted
June 11, 2012
First Posted
June 18, 2012
Study Start
May 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope
Contact the study team to confirm eligibility.
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 14, 2014
Record last verified: 2014-04
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Source: ClinicalTrials.gov.
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