Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2016-01-31

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.

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Detailed Description

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Conditions

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Syncope, Vasovagal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

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

Group Type PLACEBO_COMPARATOR

Pacemaker with Closed Loop Stimulation (CLS sensor)

Intervention Type DEVICE

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

CLS group

pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)

Group Type EXPERIMENTAL

Pacemaker with Closed Loop Stimulation (CLS sensor)

Intervention Type DEVICE

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

Interventions

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Pacemaker with Closed Loop Stimulation (CLS sensor)

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

Intervention Type DEVICE

Other Intervention Names

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BIOTRONIK Neuromediated Syncope

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

* 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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No