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ISSUE3: International Study on Syncope of Uncertain Etiology 3
This study is currently recruiting participants.
Verified by Medtronic Bakken Research Center, January 2009
Sponsored by: Medtronic Bakken Research Center
Information provided by: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00359203
  Purpose

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 Intervention Phase
Syncope
Device: pacemaker
Phase IV

MedlinePlus related topics: Fainting
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-Mediated Syncope

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • Time to first syncopal recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary end-points: findings at the time of syncopal recurrence in the control group (reproducibility of responses) and predictive value of Tilt Testing. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 710
Study Start Date: September 2006
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
2: Active Comparator
Active pacemaker
Device: pacemaker
Any pacemaker model with Rate Drop Response algorhythm

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00359203

Contacts
Contact: Nicoletta Grovale +39-3358200782 nicoletta.grovale@medtronic.com
Contact: Michele Brignole, MD +39-0185329569 mbrignole@asl4.liguria.it

Locations
Italy
Medtronic Italia S.p.A. Recruiting
Rome, Italy, 00193
Contact: Nicoletta Grovale     +390632814205     nicoletta.grovale@medtronic.com    
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna
  More Information

Responsible Party: Ospedali del Tigullio, Lavagna ( Michele Brignole )
Study ID Numbers: ISS3
Study First Received: July 31, 2006
Last Updated: January 13, 2009
ClinicalTrials.gov Identifier: NCT00359203  
Health Authority: Italy: Ministry of Health

Keywords provided by Medtronic Bakken Research Center:
syncope
implantable loop recorder

Study placed in the following topic categories:
Signs and Symptoms
Unconsciousness
Consciousness Disorders
Neurologic Manifestations
Heart Arrest
Neurobehavioral Manifestations
Syncope

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009