Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Syncope, Vasovagal Clinical Trial

— SPAIN  

Official title:

Closed Loop Stimulation for Neuromediated Syncope

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01621464
• Other study ID #: SPAIN
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 11, 2012
• Last updated: April 11, 2014
• Start date: May 2006
• Est. completion date: January 2016

Study information

• Verified date: April 2014
• Source: Spanish Society of Cardiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 ß-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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Syncope
• Syncope, Vasovagal

Intervention

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)

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Society of Cardiology	Biotronik SE & Co. KG

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time reduction to the first syncope	Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.	1 year	No
Secondary	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	No
Secondary	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	No