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ISSUE3: International Study on Syncope of Uncertain Etiology 3

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359203
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : November 18, 2013
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center

Study Description
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Brief Summary:
ISSUE 3 is a multi-center, prospective, randomised controlled double-blind study aimed to assess the effectiveness of pacemaker therapy for prevention of asystolic neurally-mediated syncope.

Condition or disease Intervention/treatment Phase
Syncope Device: Dual chamber pacemeker Phase 4

Detailed Description:
In asystolic neurally-mediated syncope (NMS) documented by Implantable Loop recorder (ILR), ISSUE-2, an observational trial, showed that pacemaker was effective in reducing the 1-year first syncope recurrence rate from 33% rate before implant (ILR phase 1) to 5% rate after implant (phase 2). Moreover, the control non-asystolic group still continued to have a 41% recurrence rate after the first recurrence of syncope, thus supporting the conclusion that the reduction with pacemaker was due to the beneficial effect of pacemaker itself and not to other factors. However a formal controlled trial is needed to confirm these findings.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 511 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope
Study Start Date : September 2006
Actual Primary Completion Date : September 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fainting

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Dual chamber pacemaker
Dual chamber pacemaker programmed ODO (switched OFF)
 Device: Dual chamber pacemeker
Other Names:
  • Any model of Medtronic pacemakers with Rate Drop Respons algorhythm:
  • K700, K900, Enpulse, Advisa, Versa
Active Comparator: Dual chamber pacemeker
Medtronic dual chamber pacemaker programmed ON and with Rate Drope Response programmed ON
 Device: Dual chamber pacemeker
Other Names:
  • Any model of Medtronic pacemakers with Rate Drop Respons algorhythm:
  • K700, K900, Enpulse, Advisa, Versa


Outcome Measures
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Primary Outcome Measures :
  1. Syncope Recurrence Rate [ Time Frame: 2 years ]
    Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Suspected or certain neurally-mediated syncope, based on the Guidelines recently published by the Task Force on Syncope of the European Society of Cardiology 2,3 (Appendix 1);
  • More than 3 syncope episodes in the last 2 years;
  • Clinical presentation of syncope of sufficient severity requiring treatment initiation in the physician's and patient's judgement.
  • Age > 40 years.
  • Negative carotid sinus massage.
  • Patients accept to have an ILR implantation.

Exclusion criteria:

  • Carotid sinus hypersensitivity
  • Suspected or certain heart disease and high likelihood of cardiac syncope:
  • Symptomatic orthostatic hypotension diagnosed by standing blood pressure measurement;
  • Loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy);
  • Subclavian steal syndrome;
  • Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator;
  • Patient compliance doubtful;
  • Patient geographically or otherwise inaccessible for follow-up;
  • Patient unwilling or unable to give informed consent;
  • Life expectancy <1 year.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359203


Locations
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Italy
Medtronic Italia S.p.A.
Rome, Italy, 00165
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
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Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00359203    
Other Study ID Numbers: ISS3
First Posted: August 1, 2006    Key Record Dates
Results First Posted: November 18, 2013
Last Update Posted: September 30, 2015
Last Verified: September 2015
Keywords provided by Medtronic Bakken Research Center:
syncope
implantable loop recorder
Additional relevant MeSH terms:
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Syncope
Unconsciousness
Consciousness Disorders
 Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases