Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Conditions

Syncope, Vasovagal

Keywords

Neuromediated syncope, Tilt test, Pacemaker, CLS sensor

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.

Gonzalo Barón‐Esquivias, Àngel Moya‐Mitjans, Jesús Martínez-Alday, Ricardo Ruiz‐Granell, Javier Lacunza et al. (9 authors)

EP Europace2019-10-0218 citations

10.1093/europace/euz294

2167Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results from the SPAIN study

Gonzalo Barón‐Esquivias, Carlos A. Morillo, Angel Moya, Jesús Daniel Martínez Alday, Ricardo Ruiz‐Granell et al. (9 authors)

European Heart Journal2019-10-011 citations

10.1093/eurheartj/ehz748.0095

Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study.

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.

2017-10-0182 citations

10.1016/j.jacc.2017.08.026

Interventions

DEVICEPacemaker with Closed Loop Stimulation (CLS sensor)

Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed