Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Study Overview
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Brief Summary
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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.

Official Title
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Closed Loop Stimulation for Neuromediated Syncope

Conditions
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Syncope, Vasovagal

Intervention / Treatment
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* Device: Pacemaker with Closed Loop Stimulation (CLS sensor)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold) | Device: Pacemaker with Closed Loop Stimulation (CLS sensor)<br>* Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)<br>* Other names: Neuromediated Syncope;|
| Experimental: CLS group<br>pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS) | Device: Pacemaker with Closed Loop Stimulation (CLS sensor)<br>* Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)<br>* Other names: Neuromediated Syncope;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neuromediated syncope, Tilt test, Pacemaker, CLS sensor