Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

This study is currently recruiting participants.

Verified June 2012 by Spanish Society of Cardiology

Sponsor:

Collaborator:

Biotronik SE & Co. KG

Information provided by (Responsible Party):

Gonzalo Barón-Esquivias, MD, PhD, FESC, Spanish Society of Cardiology

ClinicalTrials.gov Identifier:

NCT01621464

First received: June 11, 2012

Last updated: June 15, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 11, 2012

Last Updated Date

June 15, 2012

Start Date ^ICMJE

May 2006

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduction of number of syncopes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01621464 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Time reduction to the first syncope [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.
Reduction of the recurrence of presyncopal symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Official Title ^ICMJE

Closed Loop Stimulation for Neuromediated Syncope

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Syncope, Vasovagal

Intervention ^ICMJE

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)

Other Names:

BIOTRONIK
Neuromediated Syncope

Study Arm (s)

Placebo Comparator: Control
Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)

Intervention: Device: Pacemaker with Closed Loop Stimulation (CLS sensor)
Experimental: CLS group
pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Gonzalo Barón Esquivias, MD PhD FESC

gonzalo.baron.sspa@juntadeandalucia.es

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01621464

Other Study ID Numbers ^ICMJE

SPAIN

Has Data Monitoring Committee

Responsible Party

Gonzalo Barón-Esquivias, MD, PhD, FESC, Spanish Society of Cardiology

Study Sponsor ^ICMJE

Gonzalo Barón-Esquivias, MD, PhD, FESC

Collaborators ^ICMJE

Biotronik SE & Co. KG

Investigators ^ICMJE

Principal Investigator:

Gonzalo Barón Esquivias, MD PhD FESC

Spanish Society of Cardiology

Information Provided By

Spanish Society of Cardiology

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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