Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Spanish Society of Cardiology

Status and phase: Unknown; Phase 4

Conditions: Syncope, Vasovagal

Treatments: Device: Pacemaker with Closed Loop Stimulation (CLS sensor)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01621464

SPAIN

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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55 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)

Treatment:

Device: Pacemaker with Closed Loop Stimulation (CLS sensor)

CLS group

Experimental group

Description:

pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)

Treatment:

Device: Pacemaker with Closed Loop Stimulation (CLS sensor)