Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE July 31, 2006
First Posted Date  ICMJE August 1, 2006
Results First Submitted Date  ICMJE May 22, 2013
Results First Posted Date  ICMJE November 18, 2013
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE September 2006
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
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
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
Primary end-point: first syncope recurrence.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2006)
Secondary end-points: findings at the time of syncopal recurrence in the control group (reproducibility of responses) and predictive value of Tilt Testing.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ISSUE3: International Study on Syncope of Uncertain Etiology 3
Official Title  ICMJE ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Syncope
Intervention  ICMJE Device: Dual chamber pacemeker
Other Names:
  • Any model of Medtronic pacemakers with Rate Drop Respons algorhythm:
  • K700, K900, Enpulse, Advisa, Versa
Study Arms  ICMJE
  • Placebo Comparator: Dual chamber pacemaker
    Dual chamber pacemaker programmed ODO (switched OFF)
    Intervention: Device: Dual chamber pacemeker
  • Active Comparator: Dual chamber pacemeker
    Medtronic dual chamber pacemaker programmed ON and with Rate Drope Response programmed ON
    Intervention: Device: Dual chamber pacemeker
Publications * Brignole M, Menozzi C, Moya A, Andresen D, Blanc JJ, Krahn AD, Wieling W, Beiras X, Deharo JC, Russo V, Tomaino M, Sutton R; International Study on Syncope of Uncertain Etiology 3 (ISSUE-3) Investigators. Pacemaker therapy in patients with neurally mediated syncope and documented asystole: Third International Study on Syncope of Uncertain Etiology (ISSUE-3): a randomized trial. Circulation. 2012 May 29;125(21):2566-71. doi: 10.1161/CIRCULATIONAHA.111.082313. Epub 2012 May 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2012)
511
Original Enrollment  ICMJE
 (submitted: July 31, 2006)
710
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00359203
Other Study ID Numbers  ICMJE ISS3
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medtronic Bakken Research Center
Study Sponsor  ICMJE Medtronic Bakken Research Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna
PRS Account Medtronic Bakken Research Center
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP