Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

ISSUE3: International Study on Syncope of Uncertain Etiology 3

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00359203
First received: July 31, 2006
Last updated: October 24, 2013
Last verified: October 2013

July 31, 2006
October 24, 2013
September 2006
September 2011   (final data collection date for primary outcome measure)
Syncope Recurrence Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement
Primary end-point: first syncope recurrence.
Complete list of historical versions of study NCT00359203 on ClinicalTrials.gov Archive Site
Not Provided
Secondary end-points: findings at the time of syncopal recurrence in the control group (reproducibility of responses) and predictive value of Tilt Testing.
Not Provided
Not Provided
 
ISSUE3: International Study on Syncope of Uncertain Etiology 3
ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Syncope
Device: Dual chamber pacemeker
Other Names:
  • Any model of Medtronic pacemakers with Rate Drop Respons algorhythm:
  • K700, K900, Enpulse, Advisa, Versa
  • 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
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.
 
Completed
511
November 2012
September 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00359203
ISS3
Not Provided
Medtronic Bakken Research Center
Medtronic Bakken Research Center
Not Provided
Principal Investigator: Michele Brignole, MD Ospedali del Tigullio, Lavagna
Medtronic Bakken Research Center
October 2013

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