Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study) (SPAIN)

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.

Study Overview

• Status: Unknown
• Conditions: Syncope, Vasovagal
• Intervention / Treatment: Device: Pacemaker with Closed Loop Stimulation (CLS sensor)

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocío

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time reduction to the first syncope	Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.	1 year
Reduction of the recurrence of presyncopal symptoms	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.	1 year
Improvement of Quality of Life	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.	1 year

Collaborators and Investigators

• Sponsor: Spanish Society of Cardiology
• Collaborators: Biotronik SE & Co. KG
• Investigators: Principal Investigator: Gonzalo Barón Esquivias, MD PhD FESC, Spanish Society of Cardiology

Publications and helpful links

General Publications

• Baron-Esquivias G, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R, Morillo CA. Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study. Europace. 2020 Feb 1;22(2):314-319. doi: 10.1093/europace/euz294.
• Baron-Esquivias G, Morillo CA, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R. Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study. J Am Coll Cardiol. 2017 Oct 3;70(14):1720-1728. doi: 10.1016/j.jacc.2017.08.026.

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: June 11, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 18, 2012

Study Record Updates

• Last Update Posted (Estimate): April 14, 2014
• Last Update Submitted That Met QC Criteria: April 11, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Pacemaker; Neuromediated syncope; Tilt test; CLS sensor
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Autonomic Nervous System Diseases; Unconsciousness; Consciousness Disorders; Primary Dysautonomias; Orthostatic Intolerance; Syncope; Syncope, Vasovagal
• Other Study ID Numbers: SPAIN