This trial is active, not recruiting.

Condition syncope, vasovagal
Treatment pacemaker with closed loop stimulation (cls sensor)
Phase phase 4
Sponsor Spanish Society of Cardiology
Collaborator Biotronik SE & Co. KG
Start date May 2006
End date January 2016
Trial size 55 participants
Trial identifier NCT01621464, SPAIN


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose prevention
(Placebo Comparator)
Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)
pacemaker with closed loop stimulation (cls sensor) BIOTRONIK
Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)
pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)
pacemaker with closed loop stimulation (cls sensor) BIOTRONIK
Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)

Primary Outcomes

Reduction of number of syncopes
time frame: 1 year

Secondary Outcomes

Time reduction to the first syncope
time frame: 1 year
Reduction of the recurrence of presyncopal symptoms
time frame: 1 year
Improvement of Quality of Life
time frame: 1 year

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

Official title Closed Loop Stimulation for Neuromediated Syncope
Principal investigator Gonzalo Barón Esquivias, MD PhD FESC
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Spanish Society of Cardiology.