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Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

This study is currently recruiting participants.
Verified June 2012 by Spanish Society of Cardiology
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: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Syncope, Vasovagal
 Device: Pacemaker with Closed Loop Stimulation (CLS sensor)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Closed Loop Stimulation for Neuromediated Syncope

Resource links provided by NLM:

MedlinePlus related topics: Fainting
U.S. FDA Resources

Further study details as provided by Spanish Society of Cardiology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: May 2006
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)
 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
Experimental: CLS group
pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)
 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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01621464

Contacts
Contact: Gonzalo Barón Esquivias, MD PhD FESC gonzalo.baron.sspa@juntadeandalucia.es

Locations
Spain
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Principal Investigator: Gonzalo Barón Esquivias, MD PhD FESC            
Sponsors and Collaborators
Gonzalo Barón-Esquivias, MD, PhD, FESC
Biotronik SE & Co. KG
Investigators
Principal Investigator: Gonzalo Barón Esquivias, MD PhD FESC Spanish Society of Cardiology
  More Information

No publications provided

Responsible Party: Gonzalo Barón-Esquivias, MD, PhD, FESC, member of Syncope Working Group (within Section of Electrophysiology and Arrhythmias), Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT01621464     History of Changes
Other Study ID Numbers: SPAIN
Study First Received: June 11, 2012
Last Updated: June 15, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Spanish Society of Cardiology:
Neuromediated syncope
Tilt test
Pacemaker
CLS sensor

Additional relevant MeSH terms:
Syncope
Syncope, Vasovagal
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013