Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Biotronik SE & Co. KG
Information provided by (Responsible Party):
Gonzalo Barón-Esquivias, MD, PhD, FESC, Spanish Society of Cardiology
ClinicalTrials.gov Identifier:
NCT01621464
First received: June 11, 2012
Last updated: April 11, 2014
Last verified: April 2014

June 11, 2012
April 11, 2014
May 2006
January 2016   (final data collection date for primary outcome measure)
Reduction of number of syncopes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope
Same as current
Complete list of historical versions of study NCT01621464 on ClinicalTrials.gov Archive Site
  • Time reduction to the first syncope [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.
  • Reduction of the recurrence of presyncopal symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Reduction of the recurrence of presyncopal symptoms: Since the CLS sensor can detect any changes in contractility, and presyncopal symptoms are preceded by a contractility increase, it is thought that CLS group patients will suffer less from these symptoms.
  • Improvement of Quality of Life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Improvement of Quality of Life: Syncope produces uncertainties and fear to the patients. This will be checked if pacemaker implant improves QOL of these patients and if a specific programming scheme influences the outcome.
Same as current
Not Provided
Not Provided
 
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
Closed Loop Stimulation for Neuromediated Syncope

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Syncope, Vasovagal
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)
Other Names:
  • BIOTRONIK
  • Neuromediated Syncope
  • Placebo Comparator: Control
    Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)
    Intervention: Device: Pacemaker with Closed Loop Stimulation (CLS sensor)
  • Experimental: CLS group
    pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)
    Intervention: Device: Pacemaker with Closed Loop Stimulation (CLS sensor)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55
January 2016
January 2016   (final data collection date for primary outcome measure)

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
  • Patients that have signed the informed consent

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01621464
SPAIN
No
Gonzalo Barón-Esquivias, MD, PhD, FESC, Spanish Society of Cardiology
Spanish Society of Cardiology
Biotronik SE & Co. KG
Principal Investigator: Gonzalo Barón Esquivias, MD PhD FESC Spanish Society of Cardiology
Spanish Society of Cardiology
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP