NCT01621464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

April 14, 2014

Status Verified

April 1, 2014

Enrollment Period

9.7 years

First QC Date

June 11, 2012

Last Update Submit

April 11, 2014

Conditions

Syncope, Vasovagal

Keywords

Neuromediated syncopeTilt testPacemakerCLS sensor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Time reduction to the first syncope

    1 year

  • Reduction of the recurrence of presyncopal symptoms

    1 year

  • Improvement of Quality of Life

    1 year

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Device: Pacemaker with Closed Loop Stimulation (CLS sensor)

CLS group

EXPERIMENTAL

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

Device: Pacemaker with Closed Loop Stimulation (CLS sensor)

Interventions

Pacemaker with Closed Loop Stimulation (CLS sensor)DEVICE

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

Also known as: BIOTRONIK, Neuromediated Syncope
CLS groupControl

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen del Rocío

Seville, Sevilla, 41013, Spain

Location

Related Publications (2)

  • Baron-Esquivias G, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R, Morillo CA. Impact of dual-chamber pacing with closed loop stimulation on quality of life in patients with recurrent reflex vasovagal syncope: results of the SPAIN study. Europace. 2020 Feb 1;22(2):314-319. doi: 10.1093/europace/euz294.

    PMID: 31713631DERIVED

  • Baron-Esquivias G, Morillo CA, Moya-Mitjans A, Martinez-Alday J, Ruiz-Granell R, Lacunza-Ruiz J, Garcia-Civera R, Gutierrez-Carretero E, Romero-Garrido R. Dual-Chamber Pacing With Closed Loop Stimulation in Recurrent Reflex Vasovagal Syncope: The SPAIN Study. J Am Coll Cardiol. 2017 Oct 3;70(14):1720-1728. doi: 10.1016/j.jacc.2017.08.026.

    PMID: 28958328DERIVED

MeSH Terms

Conditions

Syncope, Vasovagal

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesSyncopeUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gonzalo Barón Esquivias, MD PhD FESC

    Spanish Society of Cardiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
member of Syncope Working Group (within Section of Electrophysiology and Arrhythmias)

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 18, 2012

Study Start

May 1, 2006

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

April 14, 2014

Record last verified: 2014-04

Locations

ES(1)