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.

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