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Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study) (SPAIN)

Primary Purpose

Syncope, Vasovagal

Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Pacemaker with Closed Loop Stimulation (CLS sensor)
Sponsored by
Spanish Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Syncope, Vasovagal focused on measuring Neuromediated syncope, Tilt test, Pacemaker, CLS sensor

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario Virgen del Rocío

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

CLS group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time reduction to the first syncope
Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.
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.
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.

Full Information

First Posted
June 11, 2012
Last Updated
April 11, 2014
Sponsor
Spanish Society of Cardiology
Collaborators
Biotronik SE & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT01621464
Brief Title
Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)
Acronym
SPAIN
Official Title
Closed Loop Stimulation for Neuromediated Syncope
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spanish Society of Cardiology
Collaborators
Biotronik SE & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Syncope, Vasovagal
Keywords
Neuromediated syncope, Tilt test, Pacemaker, CLS sensor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Pacemaker implanted but NO pacing (mode DDI, 30 bpm and sub-threshold)
Arm Title
CLS group
Arm Type
Experimental
Arm Description
pacemaker implanted programmed with the contractility sensor activated (mode DDD-CLS)
Intervention Type
Device
Intervention Name(s)
Pacemaker with Closed Loop Stimulation (CLS sensor)
Other Intervention Name(s)
BIOTRONIK, Neuromediated Syncope
Intervention Description
Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)
Primary Outcome Measure Information:
Title
Reduction of number of syncopes
Description
Demonstrate that pacing therapy regulated by an inotropic sensor (CLS) is effective for the suppression of the neuromediated syncope
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Time reduction to the first syncope
Description
Time reduction to 1st syncope: Time from the implantation to the 1st recurrence of the syncope.
Time Frame
1 year
Title
Reduction of the recurrence of presyncopal symptoms
Description
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.
Time Frame
1 year
Title
Improvement of Quality of Life
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonzalo Barón Esquivias, MD PhD FESC
Organizational Affiliation
Spanish Society of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
31713631
Citation
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.
Results Reference
derived
PubMed Identifier
28958328
Citation
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.
Results Reference
derived

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Closed Loop Stimulation for Neuromediated Syncope (SPAIN Study)

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