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ISSUE3: International Study on Syncope of Uncertain Etiology 3

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00359203
First received: July 31, 2006
Last updated: July 27, 2012
Last verified: July 2012
History of Changes
  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: Dual chamber pacemeker
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 511
Study Start Date: September 2006
Estimated Study Completion Date: November 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Italy
Medtronic Italia S.p.A.
Rome, Italy, 00193
Sponsors and Collaborators
Medtronic Bakken Research Center
Investigators
Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna
  More Information

Additional Information:
ISSUE3 main results publication PubMed  This link exits the ClinicalTrials.gov site

No publications provided by Medtronic Bakken Research Center

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

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT00359203     History of Changes
Other Study ID Numbers: ISS3
Study First Received: July 31, 2006
Last Updated: July 27, 2012
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013