ISSUE3: International Study on Syncope of Uncertain Etiology 3

Syncope Clinical Trial

Official title:

ISSUE3: International Study on Syncope of Uncertain Etiology 3 Pacemaker Therapy for Patients With Asystolic Neurally-mediated Syncope

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00359203
• Other study ID #: ISS3
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2006
• Last updated: September 28, 2015
• Start date: September 2006
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: November 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Syncope

Intervention

Device:
• Dual chamber pacemeker

Locations

Country	Name	City	State
Italy	Medtronic Italia S.p.A.	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Syncope Recurrence Rate	Intention to treat analysis of percentage of patients with syncope recurrence at 2 years follow-up after study arm assignement	2 years	No

External Links

•   ISSUE3 main results publication PubMed