Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Phase 4

• Conditions: Syncope, Vasovagal
• Interventions: Device: Pacemaker with Closed Loop Stimulation (CLS sensor)

• Registration Number: NCT01621464
• Lead Sponsor: Spanish Society of Cardiology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-18
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-11
• Last Update Posted: 2014-04-14
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	Pacemaker with Closed Loop Stimulation (CLS sensor)	Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)
CLS group	Pacemaker with Closed Loop Stimulation (CLS sensor)	pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)

Primary Outcome Measures

Name	Time	Method
Reduction of number of syncopes	1 year	Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope

Secondary Outcome Measures

Name	Time	Method
Time reduction to the first syncope	1 year	Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.
Reduction of the recurrence of presyncopal symptoms	1 year	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	1 year	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.

Trial Locations

Locations (1)

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain