Clinical trial NCT01621464: Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
Official title: Closed Loop Stimulation for Neuromediated Syncope
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Syncope, Vasovagal
Keywords: Neuromediated syncope
Tilt test
Pacemaker
CLS sensor
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
Collaborators: name: Biotronik SE & Co. KG
First posted: 2012-06-18
Enrollment: 55
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Reduction of number of syncopes
timeFrame: 1 year
Secondary outcomes:
measure: Time reduction to the first syncope
timeFrame: 1 year
measure: Reduction of the recurrence of presyncopal symptoms
timeFrame: 1 year
measure: Improvement of Quality of Life
timeFrame: 1 year
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: Spanish Society of Cardiology
name: Gonzalo Barón Esquivias, MD PhD FESC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.